Aktualne oferty pracy związane z Global Clinical Operations Lead - Warszawa, Mazovia - TN Poland
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3 tygodni temu
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Clinical Team Lead II Professional
3 dni temu
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Global Clinical Operations Lead
1 tydzień temu
As a member of the extended global study team, the Global Clinical Operations Lead is responsible for supporting the delivery of clinical studies within Global Medicines Development (GMD). This involves working cross-functionally with internal and external partners to ensure study delivery to time, cost, and quality objectives.
Main Accountabilities:- Leading/contributing to the preparation of delegated study documents and external service provider-related documents;
- Maintaining and facilitating interactions with internal functions including Enablement, Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance, and external functions including CROs and other external service providers;
- Contributing to the planning and conduct of internal and external meetings, including Investigators' and Monitors' meetings;
- Ensuring the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers;
- Proactively contributing to risk and issue identification and development of mitigation and/or action plans;
- Verifying that all study documents in scope of responsibilities are complete and verified for quality in the Trial Master File;
- Supporting Global Study Associate Director with budget management and project management as per agreed delegation;
- Managing CRO Project Manager for outsourced studies to ensure study delivery according to agreed timelines, budget, and quality standards.
This role requires excellent communication and relationship-building skills, as well as knowledge of international guidelines ICH/GCP and experience from within the pharmaceutical industry or similar organization.
