Clinical Trial Manager I – Hybrid (Bucharest)
syneoshealth · ROU-Client
Job description
About the role
Syneos Health is seeking a Clinical Trial Manager I to support real‑world late‑phase studies in Bucharest. The role involves site qualification, monitoring, data verification and ensuring compliance with regulatory and GCP standards.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits, both on‑site and remotely.
- Review source documents, verify data entry in case report forms, and resolve queries within agreed timelines.
- Manage investigational product inventory, reconciliation, and compliance with protocol and labeling requirements.
- Document activities through letters, trip reports and logs, and support recruitment, retention and audit readiness.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Excellent communication and interpersonal skills with the ability to travel up to 75%.
Required skills
- Good Clinical Practice (GCP) compliance
- ICH guideline familiarity
- Electronic data capture systems
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Published 4 ore în urmă
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syneoshealth
ROU-Client
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