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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
- Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis.
- Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track.
- Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
- Verifies and provides input into the country allocation and oversees trial feasibility.
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
- In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
- Prepares and implements amendments of core documents, including training material updates/retraining as needed.
- Supports authority/ethics response to requests as applicable.
- Collaborates with other functions, ensuring timely cleaning and delivery of clinical trial data.
- Coordinates and supports trial medical writer in providing the CTR.
- Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
- Supports results/documents disclosure of global registries.
Requirements
What you’ll need- Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
- Fluency in written and spoken English required
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines/directives.
- Demonstrated interpersonal & leadership skills.
- Ability to understand and implement the strategic direction and guidance for respective clinical studies.
- Effective communication skills via verbal, written and presentation abilities.
Benefits
Comp & perks- Parexel is a leading global clinical research organization providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry
- Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise
- Improving the world's health
- Advancing clinical research in healthcare’s most complex areas
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementbudget oversighttrial feasibility assessmentclinical quality monitoringdata cleaningdocument archivingKPI managementrisk monitoringamendment preparationvendor management
Soft Skills
leadershipinterpersonal skillseffective communicationstrategic direction implementationteam collaborationproblem-solvingadaptabilitytime managementpresentation skillsstakeholder engagement