Global Study Leader

Responsibilities

• Manage fully independently the overall coordination of all types of studies (Phase I to Phase III, standard or non-standard project, collaborative, multi country) according to ICH/GCP and GSK SOPs for a large, complex project (complex environment - large number of countries and regions where supra-study coordination is key, multi-subproduct, big efficacy studies with > 10.000 subjects) or a series of smaller projects regrouped for a common characteristic (e.g. early product).
• Ensure operational assessment and make final and complex operational decisions regarding project/studies. Be the reference for study management and coordination. Interact with senior management (ex. lead CDM) or project team to advise and ensure the best operational approach and ensure liaison with other dpts (Vaccines Supplies for Clinical Studies - CTSU, Laboratory and Serology Analysis -CIPLA...).
• Responsible for operational risk evaluation at project level (prioritization) and propose strategies to meet overall timeline goals. If applicable define, develop and follow-up KPIs.
• Define and drive business cases for process improvements/adaptations and think mid/long term, value added/cost effectiveness, ensure all key partners are involved and committed.
• Develop and provide status reports for different types of management meetings and senior management, analyze situation at the central and local level, establish appropriate action plan and follow its implementation. Involve Regional Clin Ops Heads and other key partners as appropriate.
• Budget : review, negotiate and approve SBB for study management, monitoring and logistics costs
• Review and select external vendors in collaboration with the Outsourcing manager, Procurement and Legal. Facilitate the development of contracts (advise on requirements for getting realistic bids, contract, and price),

Profile

• University degree in sciences or equivalent background
• Excellent knowledge and understanding of Global Study Management roles and activities
• Advanced knowledge ICH-GCP.
• Excellent knowledge of written & spoken English, Knowledge of French is an asset.
• Knowledge of Regional organization and understanding of Local Operating Countries structure.
• Intensive knowledge of project vaccine, CDP, Target Product Profile for
• At least 8 years experience in clinical trials environment and ideally minimum 3-4 years in a GSM role or similar (preferably within GSK Bio )
• Proven experience in clinical project planning, implementation and issues resolution