Global Studies Leader

Description

• 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.
• 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.
• 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.
• Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
• Leads the identification and selection of vendors and ensures cross functional input into the scope of work.
• Inputs into the contract and budget negotiation led by Business Manager.
• Accountable for performance, issues and their resolution to ensure studies are delivered in line with the agreed scope of work.
• Identifies and contributes to areas of best practice and process improvements Cross study review of quality, productivity and efficiency.
• Incorporates learnings and recommendations from study debriefs and best practices.
• Contributes to functional excellence activities. Leads study debriefs (as appropriate).
• As part of a clearly defined development plan, can take responsibility for additional activities in support of project level planning and implementation project.

• Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies.
• Demonstrated consistent achievement of team delivery against commitments and goals.
• Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
• Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes.