Clinical Project Manager

Upsilon Global; Bordeaux; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Upsilon Global is seeking an experienced Freelance Clinical Project Manager to oversee a Haematology Gene Therapy study in France. The role involves managing clinical trial execution, ensuring compliance with regulations, and leading research teams. Candidates should have significant project management experience and knowledge of gene therapy regulations.

Qualifications

• Minimum 5 years of clinical trial project management experience.
• Experience in Haematology Gene Therapy is a strong advantage.
• In-depth knowledge of EU clinical trial regulations and GCP guidelines.

Responsabilités

• Oversee all aspects of clinical trial execution, ensuring adherence to timelines, budgets, and quality standards.
• Manage regulatory submissions and ethics committee documentation.
• Monitor site activation, patient recruitment, and ongoing study progress.

Connaissances

Leadership

Communication

Problem-solving

Description du poste

Freelance CPM - France- Haematology Gene-Therapy

Upsilon Global is seeking an experienced Freelance Clinical Project Manager to oversee a Haematology Gene Therapy study in France.

• FTE : 0.5
• Therapeutic Area : Hematology Gene Therapy
• Location : France

Key Responsibilities :

• Oversee all aspects of clinical trial execution, ensuring adherence to timelines, budgets, and quality standards.
• Manage regulatory submissions and ethics committee documentation in line with French and EU requirements.
• Monitor site activation, patient recruitment, and ongoing study progress, proactively addressing challenges.
• Collaborate closely with sponsors, investigators, vendors, and regulatory authorities to ensure smooth study operations.
• Identify study risks and implement effective mitigation strategies throughout the project lifecycle.
• Provide leadership and guidance to clinical research teams, supporting training and performance.
• Ensure compliance with ICH-GCP, local regulations, and gene therapy-specific guidelines.

Requirements :

• Minimum 5 years of clinical trial project management experience.
• Experience in Haematology Gene Therapy is a strong advantage.
• In-depth knowledge of EU clinical trial regulations and GCP guidelines.
• Strong leadership, communication, and problem-solving skills.
• Fluency in English required; French is a plus.

For more details please contact Amani Manaka or call [phone]