Clinical Project Manager

il y a 2 semaines

BoisColombes, Île-de-France Chiesi Group Temps plein
Purpose

As a Clinical Project Manager at Chiesi Group, you will be accountable for the coordination of operational management of assigned projects to develop compounds in line with our goals and medical/scientific standards. Your key responsibilities will include communication with all stakeholders on the progress of the study and maintaining and respecting budget according to the study signed contract.

Main Responsibilities
  • Manage a portfolio of clinical trials, ensuring adherence to scope of work within timelines and budget.
  • Collaborate with Clinical CRO/Providers to ensure successful planning and execution of clinical studies.
  • Act as primary contact for Clinical (CRO) and internal customers, representing the Study Team for operational part of the clinical trials allocated to you.
  • Review study-related documents prepared by CRO and perform co-monitoring when needed.
  • Manage the study eTMF with the Clinical Trial Administrator (CTA) and ensure compliance with ICH/GCP and company SOPs.
  • Prepare and coordinate scientific meetings, including investigators' meetings, scientific/safety board meetings, and data reviews.
  • Manage the preparation of experts/KOLs contracts and study results, including the Clinical Study Report (CSR) and its approval.
Requirements
  • At least 3 years of experience in a similar position in a pharmaceutical company or CRO.
  • Track record of achievements in successful planning and execution of at least 5 clinical studies.
  • Degree in Life Sciences (biological science, pharmacy, or other health-related discipline) or equivalent.
  • Excellent communication and project management skills.
Language

English (5 or more)

Technical Skills

Knowledge of principles of clinical study design, clinical research statistics, planning tools, and planning principles. Familiarity with ICH/GCP and company SOPs, as well as GLP for bio-analytical assays (for clinical pharmacology studies).

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