Description
Duties:- Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans outlined by the clinical development plan.
- Builds and maintains effective high performing teams with clear roles, responsibilities and accountabilities for members.
- Chairs team meetings.
- Primary contact for key stakeholders.
- Ensures study team receives study specific and therapeutic training. Creates and manages study timelines, budget, resource, risk and quality plans.
- Drives setting of study team goals and milestones and monitors progress.
- Establishes and maintains accurate study level timeline and resourcing plans and works with Functional Management to have correct resources in place.
- Leads development of protocol level feasibility and finalizes country selection with OPL input.
- Ensures all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF and SSPM (study-specific procedures manual).
- Accountable for the drug supply requirements and availability across studies in liaison with the Pharma Technical Drug Supplies.
- Accountable for study budgets, with appropriate input from the GSM to ensure efficient expenditure and minimal variance between actual and planned spend.
- Accountable for accuracy of forecasting at RFP rounds and ensuring adjustments are made as necessary.
- Ensures CTMS is updated and accurate. Ensure clinical data are reviewed in accordance with study Data Quality plans.
- Oversees the safety reporting activities and ensures reporting timelines are met.
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