Clinical Trial Manager – Future Roles
syneoshealth · ROU-Bucharest-Hybrid
Job description
About the role
Syneos Health is seeking a Clinical Trial Manager for future roles in Romania. The position involves overseeing site qualification, initiation, monitoring, and close‑out activities while ensuring compliance with regulatory and GCP standards.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and protocol compliance.
- Review source documents, verify data entry in CRFs, resolve queries, and support electronic data capture requirements.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Document activities through letters, trip reports, and logs; support recruitment, retention, and audit readiness.
- Collaborate with project teams, attend investigator and sponsor meetings, and act as liaison for site personnel.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent 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‑GCP compliance
- Source document review and data verification
- Electronic data capture (EDC) systems
- Investigational product (IP) handling and inventory management
- Query resolution techniques
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Published 14 ore în urmă
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syneoshealth
ROU-Bucharest-Hybrid
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