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Clinical Trial Manager I – Hybrid in Bucharest

syneoshealth · ROU-Client

New
Hybrid 🇬🇧 English
ICH Guidelines

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 protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits, both on‑site and remotely.
  • Review source documents, verify data entry in CRFs, and resolve queries within agreed timelines.
  • Manage investigational product inventory, reconciliation, and compliance with labeling and storage requirements.
  • Document activities through letters, trip reports, and logs, and support recruitment and retention strategies.

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 ability to travel up to 75%.

Required skills

  • Good Clinical Practice (GCP) compliance
  • ICH‑GCP and regulatory guideline knowledge
  • Electronic Data Capture (EDC) systems proficiency

Questions fréquentes

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Source : ats:workday

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Published 3 hours ago

Expires 1 month from now

3 views · 0 interested

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syneoshealth

ROU-Client