Clinical Trial Manager – Future Roles
syneoshealth · ROU-Bucharest-Hybrid
Job description
About the role
Syneos Health is seeking a Clinical Trial Manager for upcoming opportunities in Romania. The role will involve overseeing site qualification, initiation, monitoring, and close‑out activities for real‑world late‑phase studies, ensuring compliance with regulatory and GCP standards.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remote) while maintaining ICH‑GCP and protocol compliance.
- Review source documents, verify data entry in case report forms, and drive query resolution to meet timelines.
- Manage investigational product inventory, reconciliation, and ensure proper handling according to protocol and local regulations.
- Document activities through confirmation letters, trip reports, and other required project documents.
- Support subject recruitment, retention, and awareness strategies and act as liaison with site personnel.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
- Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Willingness to travel up to 75% of the time.
Required skills
- Good Clinical Practice (GCP) and ICH guideline expertise.
- Electronic data capture (EDC) systems proficiency.
- Strong computer skills and ability to adopt new technologies.
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Published 3 hours ago
Expires 1 month from now
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syneoshealth
ROU-Bucharest-Hybrid
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