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Clinical Trial Manager I – Hybrid (Bucharest)

syneoshealth · ROU-Client

New
Hybrid Junior 🇬🇧 English
ICH guidelines Electronic data capture

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

Questions fréquentes

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Source : ats:workday

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Published 4 ore în urmă

Expires peste 1 lună

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syneoshealth

ROU-Client