Found Description
Responsibilities
- Lead and manage a team of Clinical Research Associates, providing line management and career development
- Maintain site management and monitoring responsibilities for assigned sites
- Conduct Pre-Study, Initiation, Interim, and Closeout monitoring visits in accordance with ICH GCP
- Develop and maintain study monitoring plans, templates, and tools
- Perform centralized monitoring activities to ensure data quality and mitigate study risks
- Provide oversight of study monitoring through report reviews and co-monitoring visits
- Support the development and revision of SOPs and clinical systems
Requirements
- Bachelor’s degree in a relevant field or RN
- 7+ years in the clinical trial industry with at least 5 years of clinical monitoring
- Experience with complex therapeutic areas, in‑patient trials, and blinded trials
- Experience managing a clinical monitoring te...