Local Study Associate Director
On-siteReading, England, United Kingdom
Job Summary
Lead Local Study Teams at country level to deliver clinical study components according to agreed resources, budget, and timelines while complying with Sponsor Procedural Documents, ICH-GCP, and local regulations. Identify, qualify, initiate, monitor, and close sites; coordinate site selection, qualification visits, and regulatory submissions to EC/IRB and Regulatory Authorities. Manage country financial Study Management Agreements, budgets, and drug activities from purchase through destruction. Set up studies in CTMS and local websites; oversee monitoring activities from activation to closure, review reports, and facilitate resolution of complex issues. Organize team meetings, drive patient recruitment strategies, and manage risk plans. Report study progress to Global leadership and contribute to process improvements and audit readiness.
Required Qualifications
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies)
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
- Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas
- Good knowledge of the Drug Development Process
- Excellent understanding of the Clinical Study Process including monitoring
- Very good understanding of the Study Drug Handling Process and the Data Management Process
- Excellent project management skills
- Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills
- Excellent knowledge of spoken and written English
- Good ability to learn and to adapt to work with IT systems
- Ability to travel nationally and internationally as required
- Candidates based in the listed location/s will be considered
- Candidates based outside of these locations will not be considered
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