Description
Responsibilities:- 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.
- Creates and manages study timelines, budget, resource, risk and quality plans.
- Leads development of protocol level feasibility and finalizes country selection.
- Oversees the development and active management of the study patient recruitment strategies.
- Accountable for study budgets to ensure efficient expenditure and minimal variance between actual and planned spend.
- 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.
- Ensures study adherence to ICH/GCP and SOPs.
Skills / Experience:
- Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
- 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 Project Management
Education: Life sciences degree or nursing equivalent
To find out more about Real please visit www.realstaffing.com