Clinical Project Manager

ARTO; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A biotechnology company in Paris is seeking an experienced Clinical Trial Manager to oversee operational aspects of clinical trials. The ideal candidate should have strong knowledge of regulatory compliance, excellent communication skills in English and French, and the ability to manage multiple tasks effectively. This role is pivotal in ensuring the trials are conducted smoothly and within compliance. Join us in advancing innovative cancer therapies.

Qualifications

• Strong understanding of regulatory and safety aspects of clinical trials.
• Good working knowledge of GCP, ICH, and EMA regulations.
• Excellent communication and presentation skills in English and French.

Responsabilités

• Lead and oversee all operational aspects of assigned clinical trials.
• Supervise and coordinate CROs and study sites.
• Manage timelines, budgets, and resources for studies.

Connaissances

Regulatory aspects of clinical trials

Good Clinical Practice (GCP)

Document writing

Communication skills in English and French

Vendor management

Organizational skills

Adaptability

Description du poste

The client is a clinical-stage biotechnology company focused on developing Oncology (Haem-Onc) therapies that modulate the immune system to improve survival rates in cancer and related conditions. They are now progressing into Phase 2 and 3 clinical trials.

Duties :

• Lead and oversee all operational aspects of assigned clinical trials, ensuring compliance with regulations and Good Clinical Practice (GCP).
• Supervise and coordinate CROs, study sites, and local study teams to ensure smooth trial execution.
• Manage timelines, budgets, and resources to deliver studies on schedule and within scope.
• Collaborate cross-functionally with regulatory, quality, manufacturing, and medical teams.
• Contribute to the development and execution of clinical development plans.

Skills

• Strong understanding of regulatory and safety aspects of clinical trials, including clinical trial master files and general clinical study documentation.
• Good working knowledge of GCP, ICH, and EMA regulations; familiarity with FDA regulations is a plus.
• Strong document writing skills for submissions and communications with competent authorities.
• Excellent communication and presentation skills in both English and French.
• Proven external vendor management and business communication abilities, with leadership potential.
• Strong organizational skills with attention to detail and the ability to manage multiple tasks simultaneously.
• Ability to adapt to change and manage resources efficiently with a focus on outcomes.