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About the role
Key responsibilities & impact- Provides operational leadership throughout the study lifecycle
- Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors
- Provides quality oversight and coordination of regional and country operations
- Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs
- Ensures overall vendor oversight for vendors managed by SOMs
- Accountable for study management and oversight of all study management functions
- Develops and provides key inputs to clinical trial budget
- Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock
- Serves as technical expert for study management systems and processes
Requirements
What you’ll need- Experience in clinical research and/or study management
- 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
- Exceptional knowledge of study management processes and deliverables
- Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study
- Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables
- Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
Benefits
Comp & perks- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
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 researchstudy managementvendor oversightbudget managementcost projectionsGood Clinical Practices (GCPs)monitoringregulatory operationsstudy management systemsfeasibility assessment
Soft Skills
operational leadershipcommunicationteam coordinationproblem-solvingadaptabilityattention to detailstrategic thinkingtime managementcollaborationclient relations