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Clinical Operations Manager
2 weeks ago
We are seeking a highly skilled Clinical Operations Manager to join our team. As a Clinical Operations Manager, you will be responsible for overseeing the execution of clinical studies at sites across the region.
Key Responsibilities- Accountable for all activities related to site-related study execution, including start-up, execution, and close-out.
- Ensure timely and within-budget study execution, including country and site feasibility assessments.
- Oversee site evaluation/selection, contract/budget negotiation, regulatory/submissions startup, issue management, relationship management, monitoring, and site closure.
- Provide local regulatory and legal expertise, ensuring adherence to federal regulations, applicable local regulations, GCPs, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.
- Bachelor's or equivalent degree in a health-related field (e.g., medical, scientific, nursing, pharmacy).
- Minimum 3 years of experience in site monitoring processes.
- Strong planning, organizational skills, flexibility, and ability to lead country projects with competing deadlines.
- Experience across multiple therapeutic areas and study phases.