Description
Responsibilities:Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans. 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. Ensures all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF, etc. Accountable for study budgets. 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.
Skills Required:
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.
Self-motivated and achievement driven.
Excellent written and verbal communications skills
To find out more about Real please visit www.realstaffing.com