When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Project ManagementAssist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Statistical Programming for Assigned ProjectsDeliver best value and high quality service.Check own work in an ongoing way to ensure first-time quality.Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.TrainingMaintain and expand local and international regulatory knowledge within the clinical industry.Develop knowledge of SAS and processes/procedures within other Parexel functional areas.Provide relevant training and mentorship to staff and project teams as appropriate.GeneralMaintain all supporting documentation for studies in accordancewith SOPs/Guidelines to ensure traceability and regulator compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively participate in process/quality improvement initiatives.Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).Skills: Excellent analytical skills.Proficiency in SAS.Knowledge and understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Ability to manage competing priorities and flexibility to change.Attention to detail.Ability to successfully work as part of a global team.Work effectively in a quality-focused environment.Effective time management in order to meet daily metrics or team objectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment to quality management, and problem solving.Knowledge and Experience:Competent in written and oral English.Good communication skills.Education:Educated to degree level in a relevant discipline and/or equivalent work experience.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Operational ExecutionProduction and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniquesUnderstand and apply moderately advanced statistical methodsCoordinate and lead a project team to successful completion of a project within given timelines and budgetInteract with clients as key contact with regard to statistical and contractual issuesAssist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documentsCheck own work in an ongoing manner to ensure first-time qualityProvide training in statistical analysis to internal clientsProactively participate in and/or lead process/quality improvement initiativesTravel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting and discussing study resultsGeneral ActivitiesMentor and train junior members of the departmentAdditional responsibilities as defined by supervisor/managerBusiness DevelopmentSupport of Business Development, eg by attending and preparing bid defense meetingsSkills:Good analytical skillsGood project management skillsProfessional attitudeAttention to detailA good understanding of statistical issues in clinical trialsPrior experience with SAS programming desirableAbility to work independentlyGood mentoring/leadership skillsKnowledge and Experience:PhD in Statistics or related discipline entry level, MS in Statistics or related discipline with some experienceThe knowledge of pharmacokinetic data is an advantageCompetent in written and oral English in addition to local languageEducation: PhD in Statistics or related discipline, MS in Statistics or related discipline
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Core services provided by Project Specialist I and Project Specialist II include, but are not limited to: Project Management Plans initial set up and maintenance with Project Leader inputMaintenance of selected information in the integrated project management systemProject reports, compliance and other metrics for project operational review, client and internal reporting and project oversight Initial Review of selected financial areas. Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items Oversight of project team list, project system accesses and respective reviewsProject Initiation ManagementProject Specialist I and II: Updating and customizing of systems and tools and project plans according to applicable SOPs; Supporting vendor selection; Creating of Project specific training curriculum; Reviewing time booking and following up on needed corrections analyzing overconsumption with FL input ready for PL review; Reviewing pass – through costs; Cooperating with TMF lead, IPO and eCBL on set up on TMF and site pay; Cooperating with Project Data Coordinator to set up system access management process; Working with PL and FLs to ensure project resources are requested in line with project scope; Collecting, distributing and tracking insurances and Letter of Authorization.The Project Specialist I may require mentoring and line manager oversight particularly for responsibilities related to analysis of financial data or activities that require team management skills. Project Execution and Control ManagementProject Specialist I: Study reporting and distribution to FLs and project team. Maintaining systems and tools according to applicable SOPs.Project Specialist II: Study reporting and analysis with subsequent highlighting issues for project team. Maintaining systems and tools according to applicable SOPs.Project Integration ManagementProject Specialist I: Maintaining consistent coherent project management plans, reviewing plans with PL and distributing to the different functions. Reviewing pass – through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation and action follow of Project Operational review meetings; Providing reports, metrics and initial analysis for informed Project Leader decision making and client reporting. Maintaining oversight on project system accesses and review.The Project Specialist I may require mentoring and line manager oversight particularly for responsibilities related to analysis of financial data or activities that require team management skills. Project Specialist II: Maintaining consistent coherent project management plans, including communication, coordinated planning of the different project activities and input from the different functions; collaborating with the PL and FLs to execute the plans. Reviewing pass – through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation conduct and action follow of Project Operational review meetings; Providing reports, metrics and analysis for informed Project Leader decision making client reporting and risk management. Maintaining oversight on project system accesses and review. If delegated, provide oversight on defined project management areas on behalf of the Project Leader.Project Meeting ManagementProject Specialist I: Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Supporting tracking and follow-up of action items.Project Specialist II: Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Reporting of owned responsibilities during meeting attendance; Supporting tracking and follow-up of action items.Project Vendor ManagementProject Specialist I and II: Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation. Performing vendor invoice review.Project Closure ManagementProject Specialist I and II: Close out responsibilities: utilizing the close out checklist and communicating to drive timely operational projects close out with the different functions. Collaborating with PL on ensuring that systems are closed, documents are archived, and final work is handed over to the sponsor. Support preparation of the financial close-out. Depending on level of Knowledge and experience of the Project Specialist I can be supported by a close-out SME or Line manager. Clinical Operations Leader SupportProject Specialist I and II: Supporting the Clinical Operations Leader with different responsibilities to manage CTMS system compliance, site newsletters track and analyze different reports such as site staff lists, shipment reports, laboratory reports, site contact reports, site closure activities related tracking, vendor reports, query reports and other responsibilities as delegated.SME /Mentor, if assignedProject Specialist II: Train and mentor new starters in systems and tools. Provide feedback to PS/PL Super User in CRS technology on systems and tools in order to enhance tools and processesCompetency Levels (refer to PPS Competency Guide for more detail) Project Specialist I:Project Management – BasicFinancial Management – BasicAnalytical Mindset – BasicQuality Delivery – BeginnerTeam Oriented approach – BasicOwnership – BasicCommunication – BasicClient Focused approach – BeginnerRisk Management – BeginnerProfessionalism – ProficientProject Specialist II:Project Management – ProficientFinancial Management – ProficientAnalytical Mindset – ProficientQuality Delivery – AdvancedTeam Oriented approach – AdvancedOwnership – AdvancedCommunication – AdvancedClient Focused approach – ProficientRisk Management – BasicProfessionalism – Advanced Advanced - mature understanding of competency and excellent ability to apply competency in multiple situations- capable of teaching the basics of this competency to others.Proficient - robust understanding of competency and solid acquisition of the skills required to use the competency - can successfully apply it without management supervision.Basic - understanding of the competency and has acquired the fundamental skills- can apply it under the guidance of management.Skills:Project Specialist I: Good verbal and written communication skills, as the exchange of information is a significant part of the job. Developed interpersonal skills and ability to build relationships • Attention to detail and quality of work.Client focused approach to workFlexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm Ability to prioritize workloadA willingness to work in a matrix environment and to value the importance of teamwork.Basic problem- solving ability.Project Specialist II: Professional interpersonal, verbal and written communication skills, as the exchange of information is a significant part of the jobAttention to detail and understanding how quality of own work impacts others and the business outcomesClient focused approach to workFlexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and to adopt to changes Ability to prioritize workloadWillingness to work in a matrix environment and to value the importance of teamworkAdvanced problem-solving skillsAbility to apply analytical thinking to resolve issues Knowledge and Experience: Project Specialist I: Relevant basic experience in a PS type or similar role desirableBasic knowledge of activities and procedures of the work areaGood Knowledge of Microsoft based applicationsProject Specialist II: Minimum one year experience in the PS role or more than 2 years’ experience in Clinical ResearchGood understanding of how their role integrates with others in the business in accomplishing the project deliverables and objectives of the area Experience in working globally across regions ICH /GCP knowledgeEducation Project Specialist I and II:Intermediate to Advanced English level for non-native English speakersMinimum Bachelor’s degree or equivalent degree
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Project ManagementAssist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Statistical Programming for Assigned ProjectsDeliver best value and high quality service.Check own work in an ongoing way to ensure first-time quality.Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.TrainingMaintain and expand local and international regulatory knowledge within the clinical industry.Develop knowledge of SAS and processes/procedures within other Parexel functional areas.Provide relevant training and mentorship to staff and project teams as appropriate.GeneralMaintain all supporting documentation for studies in accordancewith SOPs/Guidelines to ensure traceability and regulator compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively participate in process/quality improvement initiatives.Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).Skills: Excellent analytical skills.Proficiency in SAS.Knowledge and understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Ability to manage competing priorities and flexibility to change.Attention to detail.Ability to successfully work as part of a global team.Work effectively in a quality-focused environment.Effective time management in order to meet daily metrics or team objectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment to quality management, and problem solving.Knowledge and Experience:Competent in written and oral English.Good communication skills.Education:Educated to degree level in a relevant discipline and/or equivalent work experience.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Maintenance (from initiation through close out):Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.Address/evaluate/resolve issues pending from the previous visit, if any.Follow-up on and respond to appropriate site related questions.Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.Conduct remote visits/contacts as requested/needed.Generate visit/contact report.Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.Assess & manage test article/study supply including supply, accountability and destruction/return status.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Conduct on-site study-specific training (if applicable).Perform site facilities assessmentsRecognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolutionOverall Accountabilities from Site Identification to Close out:Ensure timely and accurate completion of project goals and update of applicable trial management systems.Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.Ensure that assigned sites are audit and inspection readyMonitor and maintain compliance with ICH-GCP and applicable international and local regulations.Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.Show commitment and perform consistent high-quality work.Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.Provide input and feedback for Performance Development Conversation(s).Proactively keep manager informed about work progress and any issues.Develop expertise to become a subject matter expert.Work in a self-driven capacity, with limited need for oversight.Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)Skills:Sound problem solving skills.Able to take initiative and work independently, and to proactively seek guidance when necessary.Advance presentation skills.Client focused approach to work.Ability to interact professionally within a client organization.Flexible attitude with respect to work assignments and new learning.Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.Willingness to work in a matrix environment and to value the importance of teamwork.Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.Strong interpersonal, verbal, and written communication skills.Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.Effective time management in order to meet study needs, team objectives, and department goals.Developing ability to work across cultures.Shows commitment to and performs consistently high-quality work.Ability to successfully work in a (‘virtual’) team environment.Consulting SkillsGreat attention to detail.Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.Holds a driver’s license where required.Knowledge and Experience:Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminologyEducation:Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Project ManagementAssist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Statistical Programming for Assigned ProjectsDeliver best value and high quality service.Check own work in an ongoing way to ensure first-time quality.Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.TrainingMaintain and expand local and international regulatory knowledge within the clinical industry.Develop knowledge of SAS and processes/procedures within other Parexel functional areas.Provide relevant training and mentorship to staff and project teams as appropriate.GeneralMaintain all supporting documentation for studies in accordancewith SOPs/Guidelines to ensure traceability and regulator compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively participate in process/quality improvement initiatives.Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).Skills: Excellent analytical skills.Proficiency in SAS.Knowledge and understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Ability to manage competing priorities and flexibility to change.Attention to detail.Ability to successfully work as part of a global team.Work effectively in a quality-focused environment.Effective time management in order to meet daily metrics or team objectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment to quality management, and problem solving.Knowledge and Experience:Competent in written and oral English.Good communication skills.Education:Educated to degree level in a relevant discipline and/or equivalent work experience.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.The Senior Data Engineer will create standardized yet customizable data visualization templates and provide study teams with high-impact graphical tools to support early development decision-making. Will also serve as a partner and point of support for clinical scientists, offering training and ongoing consultation to ensure effective use of visual analytics in study workflows. With an eye toward scalability, compliance, and scientific relevance, the Real-time Visual Analytics Specialist plays a critical role in accelerating insight generation across exploratory and safety-critical endpoints. Create and maintain standardized data visualizations to support Medical Data Review and safety signal detection, following established templates and guidance Apply defined visualization standards to generate outputs aligned with Risk-Based Quality Management (RBQM) principles and Critical to Quality (CtQ) endpoints Work under guidance to implement visual analytics within timelines tied to First Patient In (FPI) or predefined safety milestones Support documentation and quality control of visualization deliverables to ensure traceability and compliance Participate in training sessions and incorporate feedback from more experienced Real-time Visual Analytics Specialists Assist in responding to basic stakeholder requests and clarifying data availability or visualization functionality Work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding Apply judgment to address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility, and seek guidance when facing novel or ambiguous situations Adhere to functional standards by participating in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise Required experience and skills: Hold a Bachelor’s degree in life sciences, computer science, data science, bioinformatics, or a related field Have 1-3 years of experience in clinical data, visualization, or analytics; or an advanced degree with 1-3 years of equivalent work experience Proficient in tools including R Shiny & Git Experienced with programming languages including R and tidyverse Have a basic understanding of clinical trial data and common data structures (e.g., CRF data) Demonstrate strong attention to detail, logical thinking, and an eagerness to learn visualization standards and clinical workflows Show respect for cultural differences when interacting with colleagues in the global workplace Communicate effectively in English, both in writing and verbally Preferred skills: Exposure to clinical or safety data structures and terminology (e.g., adverse events, lab results, dosing) Experience with: R package development R Teal Developer experience with R shiny Claud code Familiarity with Risk-Based Quality Management (RBQM) concepts and their role in early development Interest in visual storytelling and user experience in data interpretation Ability to follow visual design templates and apply style consistency Curiosity and willingness to learn visualization standards and workflows in a regulated environment
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities: Site Management Responsibilities Contributes to the selection of potential investigators. In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulator Authorities for start-up and for the duration of the study. Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. Actively participates in Local Study Team (LST) meetings. Contributes to National Investigators meetings, as applicable. Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner. Works with data management to ensure robust quality of the collected study data. Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. Follows up on outstanding actions with study sites to ensure resolution in a timely manner. Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. Assists site in maintaining inspection ready ISF. Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. Compliance with Sponsor Standards Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). Ensures compliance with local, national, and regional legislation, as applicable. Completes timesheets accurately as required. Compliance with Parexel Standards Complies with required training curriculum. Completes timesheets accurately as required. Submits expense reports as required. Updates CV as required. Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. Skills (Essential): Excellent attention to detail. Good written and verbal communication skills. Good collaboration and interpersonal skills. Good negotiation skills. Proficient in written and spoken English language required. Fluency in local language(s) required. Skills (Desirable): Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Good analytical and problem-solving skills. Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. Knowledge and Experience (Essential): Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. Good medical knowledge and ability to learn relevant Client Therapeutic Areas. Basic understanding of the drug development process. Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Knowledge and Experience (Desired): Familiar with risk-based monitoring approach including remote monitoring. Good cultural awareness. Education: Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Other: Ability to travel nationally/internationally as Required Valid driving license per country requirements, as applicable.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Project ManagementAssist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Statistical Programming for Assigned ProjectsDeliver best value and high quality service.Check own work in an ongoing way to ensure first-time quality.Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.TrainingMaintain and expand local and international regulatory knowledge within the clinical industry.Develop knowledge of SAS and processes/procedures within other Parexel functional areas.Provide relevant training and mentorship to staff and project teams as appropriate.GeneralMaintain all supporting documentation for studies in accordancewith SOPs/Guidelines to ensure traceability and regulator compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively participate in process/quality improvement initiatives.Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).Skills: Excellent analytical skills.Proficiency in SAS.Knowledge and understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Ability to manage competing priorities and flexibility to change.Attention to detail.Ability to successfully work as part of a global team.Work effectively in a quality-focused environment.Effective time management in order to meet daily metrics or team objectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment to quality management, and problem solving.Knowledge and Experience:Competent in written and oral English.Good communication skills.Education:Educated to degree level in a relevant discipline and/or equivalent work experience.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.• Assists in coordination and administration of clinical studies from the start-up to execution and closeout• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.• Ensuresthat all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.• Contributes to the production and maintenance of study documents, ensuring template and version compliance.• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Authoring Guide for Regulatory Documents.• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.• Sets-up, populates and accurately maintains information in tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.• Manages and contributes to coordination and tracking of study materials and equipment.• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.• Leadsthe practical arrangements and contributesto the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.• Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.• Ensures compliance with Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).• Ensures compliance with local, national and regional legislation, as applicable.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Project Management:Ability to fill Statistical Programming Lead role on projects-Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.-Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.-Monitor project resourcing, project budgets, and identify changes in scope.Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Review statistical analysis plans and mock-shells.Review database set-up specifications.Interact with sponsors and internal stakeholders with regard to statistical programming issues.Assist project teams in the resolution of problems encountered in the conduct of their daily work.Statistical Programming for Assigned Projects:Deliver best value and high quality service.Check own work in an ongoing way to ensure first-time quality.Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.Produce/QC dataset specifications and other process supporting documents and submission documentation.Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.Training:Maintain and expand local and international regulatory knowledge within the clinical industry.Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas.Provide relevant training and mentorship to staff and project teams.General:Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively participate in and/or lead process/quality improvement initiatives.Provide consultancy to internal and external sponsors with regard to statistical programming tasks.Represent PAREXEL at sponsor marketing and technical meetings.Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).Skills:Excellent analytical skills.Proficiency in SAS.Extensive knowledge and understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Strong project management skills.Strong organizational skills, ability to manage competing priorities, and flexibility to change.Attention to detail.Ability to successfully lead a global team.Work effectively in a quality-focused environment.Effective time management in order to meet daily metrics or team objectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment to quality management, and problem solving.Demonstrate commitment to refine quality processes.Good presentation skills.Good business awareness/business development skills (including financial awareness).Knowledge and Experience:Competent in written and oral English.Excellent communication skills.Education:Educated to degree level in a relevant discipline and/or equivalent work experience.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Operational ExecutionCoordinate and lead a project team to successful completion of a project within timelines and budgetInteract with clients as key contact with regard to statistical and contractual issuesPerform QC of derived datasets, tables, figures and data listings produced by other members of the departmentCheck own work in an ongoing way to ensure first time qualityUnderstand and apply advanced statistical methodsLead production and quality control of randomizations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documentsProvide a supporting role as a non-voting independent statistician providing data and analysis for DMC reviewTravel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results)Business Development Support of Business Development, eg by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings for potential studies, programs of work and FSPsGeneral Activities Additional responsibilities as defined by supervisor/manager.Skills:Good analytical skillsGood project management skillsProfessional attitudeAttention to detailThorough understanding of statistical issues in clinical trialsPrior experience with SAS programming requiredAbility to work independentlyGood leadership skillsGood business awareness/ business developmentWillingness to work in a matrix environment and to value the importance of teamworkKnowledge and Experience:PhD in Statistics or related discipline with some experience or MS in Statistics or related discipline with significant experienceThe knowledge of pharmacokinetic data is an advantageCompetent in written and oral English in addition to local languageEducation:PhD in Statistics or related discipline, MS in Statistics or related discipline
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.-Conduct remote Qualification Visits (QVs).Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.Forecast, develop, manage, and revise plans and strategies for:-IRB/IEC and MoH / RA submission/approval,-Site activation,-Patient recruitment & retention.Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.Actively participate in Investigator and other external or internal meetings, audits & regulatory inspectionsWork in a self-driven capacity, with limited need for oversight.Proactively keep manager informed about work progress and any issues.Maintenance (from initiation through close out):Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.Address/evaluate/resolve issues pending from the previous visit, if any.Follow-up on and respond to appropriate site related questions.Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.Conduct remote visits/contacts as requested/needed.Generate visit/contact report.Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.Assess & manage test article/study supply including supply, accountability and destruction/return status.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Conduct on-site study-specific training (if applicable).Perform site facilities assessmentsRecognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolutionOverall Accountabilities from Site Identification to Close out:Ensure timely and accurate completion of project goals and update of applicable trial management systems.Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.Ensure that assigned sites are audit and inspection readyMonitor and maintain compliance with ICH-GCP and applicable international and local regulations.Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.Show commitment and perform consistent high quality work.Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.Provide input and feedback for Performance Development Conversation(s).Proactively keep manager informed about work progress and any issues.Develop expertise to become a subject matter expert.Work in a self-driven capacity, with limited need for oversight.Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)Skills:Problem solving skillsAble to work independently, seeking/taking guidance when necessary.Sound presentation skills.Client focused approach to work.Ability to interact professionally within a client organization with the support of manager or CRAII/IIIFlexible attitude with respect to work assignments and new learning.Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).Willingness to work in a matrix environment and to value the importance of teamwork.Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.Sound interpersonal, verbal, and written communication skills.Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.Developing ability for effective time management in order to meet study needs, team objectives, and department goals.Developing ability to work across cultures.Shows commitment to and performs consistently high quality work.Ability to successfully work in a (‘virtual’) team environment.Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.Attention to detail.Holds a driver’s license where requiredKnowledge and Experience:Previous relevant work experience preferred.Education:Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experienceKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.-Conduct remote Qualification Visits (QVs).Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.Forecast, develop, manage, and revise plans and strategies for:-IRB/IEC and MoH / RA submission/approval,-Site activation,-Patient recruitment & retention.Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.Actively participate in Investigator and other external or internal meetings, audits & regulatory inspectionsWork in a self-driven capacity, with limited need for oversight.Proactively keep manager informed about work progress and any issues.Maintenance (from initiation through close out):Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.Address/evaluate/resolve issues pending from the previous visit, if any.Follow-up on and respond to appropriate site related questions.Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.Conduct remote visits/contacts as requested/needed.Generate visit/contact report.Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.Assess & manage test article/study supply including supply, accountability and destruction/return status.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Conduct on-site study-specific training (if applicable).Perform site facilities assessmentsRecognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolutionOverall Accountabilities from Site Identification to Close out:Ensure timely and accurate completion of project goals and update of applicable trial management systems.Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.Ensure that assigned sites are audit and inspection readyMonitor and maintain compliance with ICH-GCP and applicable international and local regulations.Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.Show commitment and perform consistent high quality work.Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.Provide input and feedback for Performance Development Conversation(s).Proactively keep manager informed about work progress and any issues.Develop expertise to become a subject matter expert.Work in a self-driven capacity, with limited need for oversight.Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)Skills:Problem solving skillsAble to work independently, seeking/taking guidance when necessary.Sound presentation skills.Client focused approach to work.Ability to interact professionally within a client organization with the support of manager or CRAII/IIIFlexible attitude with respect to work assignments and new learning.Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).Willingness to work in a matrix environment and to value the importance of teamwork.Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.Sound interpersonal, verbal, and written communication skills.Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.Developing ability for effective time management in order to meet study needs, team objectives, and department goals.Developing ability to work across cultures.Shows commitment to and performs consistently high quality work.Ability to successfully work in a (‘virtual’) team environment.Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.Attention to detail.Holds a driver’s license where requiredKnowledge and Experience:Previous relevant work experience preferred.Education:Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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