Clinical Project Manager

il y a 2 semaines


BoisColombes, Île-de-France Chiesi Group Temps plein
Job Summary

Chiesi Group is seeking a highly skilled Clinical Project Manager to lead the operational management of assigned projects. The successful candidate will be accountable for coordination, communication, and budget management to develop compounds in line with Chiesi goals and medical/scientific standards.

Main Responsibilities
  • Manage 1-3 clinical trials, depending on size, complexity, phase of development, and therapeutic area.
  • Coordinate with Clinical CRO/Providers, acting as primary contact for Clinical (CRO) and internal customers.
  • Ensure adherence to scope of work within timelines and budget.
  • Review study-related documents prepared by CRO and perform co-monitoring when needed.
  • Collaborate in the set-up and maintenance of the Study Risk Register.
  • Manage the study eTMF with the Clinical Trial Administrator (CTA).
  • Prepare and coordinate scientific meetings, including investigators' meetings and safety board meetings.
  • Manage Clinical Trial Supplies and ensure compliance with SOPs and quality standards.
  • Provide clinical operations input during study design and Clinical Protocol Approval Committee (CPAC) meetings.
  • Budget Management: prepare and present budget in collaboration with Clin Ops Lead and be accountable for budget management for ongoing studies.
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 or equivalent.
  • Knowledge of principles of clinical study design, Clinical Research Statistics, planning tools, and ICH/GCP.

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