On behalf of our client, an international pharmaceutical company, we are looking for an experienced Global Studies Leader
- Leads one or more cross functional global Study Management Teams (SMTs)
- Accountable for efficient delivery of clinicalstudies through all phases (phase 1b-IV) and stages (start-up, conduct and close down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
- Provides direction and leadership to one or more global Study Management Teams (SMTs)
- Builds and maintains effective high performing SMTs
- Chairs SMTmeetings and other meetings involving external stakeholders (Investigator, Steering Committee, Vendors as appropriate).
- Represents the SMT atvarious cross-functional teams (e.g., Global Development Team GDT, Clinical Filing Team)
- 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 milestones
- Leads development of protocol level feasibility and finalises country selection with OPL input.
- Accountable for study budgets
- Accountable for vendor performance
- 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.
- Clear understanding and experience applying ICH/GCP
- Strong knowledge and experience of the drug development process and the pharmaceutical industry
- Experienced project manager. Must have experience creating and managingcomplex study budgets.
- Strong leadership and motivational skills
- Applies critical thinking
- Ability to influence, negotiate and manage conflicts
If you believe you are matching these requirements and want to take this exciting opportunity, we look forward to receiving your online application. Only shortlisted candidates will be contacted!
Please check that your qualifications and experience match the vacancy and that you fill the required criteria. After you have submitted this application form with a current CV, we will endeavour to contact you as soon as we can.
Please submit your CV in Microsoft Word format. We are unable to accept CVs submitted in alternative formats.
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