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Clinical Trial Manager – Future Roles

syneoshealth · ROU-Bucharest-Hybrid

New
Hybrid 🇬🇧 English
Source document review Electronic data capture Query resolution

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

Questions fréquentes

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Source : ats:workday

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Published 14 ore în urmă

Expires peste 1 lună

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syneoshealth

ROU-Bucharest-Hybrid