Senior Clinical Project Lead — Global Trials & Regulatory

AB Science SA; Paris; On-site; EUR 90,000 - 130,000; Full time

Job summary

A pharmaceutical company in Paris is seeking a Clinical Project Manager to oversee the design and implementation of clinical studies. The ideal candidate will have 6-8 years of experience in clinical development, particularly in oncology or autoimmune inflammatory diseases, and a solid understanding of regulatory environments. This position offers a competitive salary package based on skills and experience.

Qualifications

• Holder of additional training in methodology (CESAM, IUD, ...).
• 6-8 years of experience in clinical development (Phase II and III).
• Experience in writing research reports and FDA regulatory dossiers.

Responsibilities

• Design and implement clinical studies.
• Prepare study protocols, amendments, and reports.
• Manage relationships with investigators and opinion leaders.

Skills

Clinical development

Regulatory knowledge

Project management

Oncology expertise

Relationship management

Education

Additional training in methodology

Job description

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