Clinical Project Manager

il y a 2 semaines


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

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 company goals and medical/scientific standards.

Key Responsibilities
  • Manage clinical trials, ensuring adherence to scope of work within timelines and budget.
  • Collaborate with Clinical CRO/Providers, acting as primary contact for Clinical (CRO) and internal customers.
  • Represent the Study Team for operational part of clinical trials allocated to you.
  • Ensure compliance to ICH/GCP and company SOPs, and manage study eTMF with the Clinical Trial Administrator (CTA).
  • Prepare and coordinate scientific meetings, and manage the preparation of experts/KOLs contract if required.
  • Ensure study results and related deliverables are prepared and reviewed in cooperation with the Medical Writer.
Requirements

At least 3 years of experience in a similar position in a pharmaceutical company or CRO, with a track record of achievements in successful planning and execution of at least 5 clinical studies.

Education

Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.

Languages

English 5 or more (1 = beginner / 6 = fluent)

Technical Skills

Knowledge of principles of clinical study design, clinical research statistics, planning tools and planning principles, ICH/GCP and company SOPs, and GLP for bio analytical assays.

Soft Skills

Familiar and up to date with relevant literature, with strong communication and collaboration skills.


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