Clinical Project Manager M/F

AB Science; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

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.
• 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.

Responsabilités

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

Connaissances

Clinical development

Regulatory knowledge

Project management

Oncology expertise

Relationship management

Pharma industry experience

Oncology / autoimmune familiarity

Formation

Additional training in methodology

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