Clinical Project Manager M/F

AB Science; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

A leading biotechnology company is seeking a Clinical Project Manager to design and coordinate clinical studies. The ideal candidate will have extensive experience in clinical development, particularly in the oncology field, and possess strong project management skills. This role involves preparing regulatory submissions and managing key relationships, offering a rewarding opportunity with competitive remuneration based on experience.

Qualifications

• 6-8 years of experience in clinical development (Phase II and III).
• Experience in writing research reports and regulatory dossiers.
• Experience in oncology or autoimmune inflammatory diseases is a plus.

Responsabilités

• Plan the clinical development program.
• Prepare study protocols, amendments, and reports.
• Manage relationships with investigators and opinion leaders.

Connaissances

Clinical Development

Project Management

Pharmaceutical Regulations

Oncology Expertise

Experience in International Development

Formation

Additional training in methodology (CESAM, IUD, …)

Description du poste

Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing:

• Plan the clinical development program
• Prepare studies protocols, amendments and reports
• Prepare regulatory dossiers
• Manage relationships with investigators and opinion leaders

Requirements

• Holder of additional training in methodology (CESAM, IUD, …)
• Successful experience of Clinical Project Manager in a pharmaceutical company or CRO
• 6-8 year’s experience in clinical development (Phase II and III)
• Experience in oncology or autoimmune inflammatory diseases would be a plus
• Experience in international development required
• Experience of the regulatory environment for clinical trials
• Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
• Based in Paris
• Salary & package to define according skills and experience