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gcp edc clinical operations ich guidelines site management📋 Description
- Serve as primary sponsor contact for US CT sites, ensuring timely communication.
- Build relationships with investigators/site staff to support engagement and readiness.
- Deliver training on protocols, operational requirements, and rationale for investigational products.
- Partner with sites to support patient recruitment and retention strategies.
- Collaborate with Clinical Ops and CROs to address compliance issues.
- Conduct remote and in-person site visits to strengthen relationships and oversight.
🎯 Requirements
- Bachelor’s degree in scientific/healthcare field; advanced degree preferred.
- 6+ years in clinical trials; strong clinical operations and study conduct.
- Prior CTL or similar role experience with investigators/site staff.
- Knowledge of GCP, ICH Guidelines, and U.S. regulatory requirements.
- Experience using IRT, EDC, and eTMF; ability to travel up to 60%.
- Strong communication, problem-solving, and relationship-building skills.
🎁 Benefits
- Annual bonus and equity compensation.
- Competitive benefits package.
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