Global Studies Leader - South San Francisco

South San Francisco  ‐ Onsite
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Keywords

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.


To find out more about Real please visit www.realstaffing.com
Start date
03/2014
From
Real Staffing
Published at
13.03.2014
Project ID:
678415
Contract type
Freelance
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