Country Study Operations Manager/Clinical Trial Manager - FSP
On-siteRemote, Oregon, United States
Job Summary
Lead study and regional country-level activities from startup through close, providing strategic planning and operational delivery for one or more studies. Serve as leader of the local study team, overseeing the preferred CRO and Country Trial Manager/Site Care Partner in accordance with the overall project plan. Manage and maintain accurate country-level plans covering timelines, budget, risk, and quality. Liaise with regulatory colleagues to agree on submission strategies for Health Authorities and Ethics Committees, while collaborating on startup and recruitment milestones. Identify, manage deviations, and implement mitigation strategies for study execution risks, including resolution of site activation escalations. Fully responsible for regional and country-level implementation of startup plans, recruitment strategies, and vendor management. Ensure follow-up on quality events, protocol deviations, data issues, and audit responses. Requires 5+ years of operational clinical trial experience with a Bachelor's degree, or 3+ years with a Master's degree.
Required Qualifications
- Bachelor's of Science or Bachelor's of Arts degree
- minimum 5 years of relevant operational clinical trial experience
- Master's of Science or Master's of Business Administration degree
- minimum 3 years of relevant operational clinical trial experience
Desired Qualifications
- A scientific or technical degree
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