Clinical Study Manager

il y a 2 semaines


Paris, Île-de-France Parexel Temps plein
Job Summary: We are seeking a highly skilled Clinical Study Manager to join our team at Parexel. The successful candidate will be responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations. Key responsibilities include preparing, reviewing, and tracking site regulatory documentation, maintaining and reviewing site performance metrics, and ensuring timely and efficient study start-up activities and milestones.

Key Accountabilities:
  • Contribute to the assessment of clinical and operational feasibility of potential studies.
  • Provide regular updates to line managers on study and planned study milestones/key issues during the start-up period.
  • Support study management and monitoring in different initiatives as agreed with line management.
  • May support site selection process by identifying and assessing potential sites/investigators.
  • Ensure timely collection and uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs, and local requirements.

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