Clinical Project Manager

JR France; Reims; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company is seeking an experienced Freelance Clinical Project Manager to oversee a Haematology Gene Therapy study in France. The role involves managing clinical trial execution, regulatory submissions, and collaborating with various stakeholders to ensure compliance and quality standards.

Qualifications

• Minimum 5 years of clinical trial project management experience.
• Experience in Haematology Gene Therapy is a strong advantage.

Responsabilités

• Oversee all aspects of clinical trial execution, ensuring adherence to timelines and budgets.
• Manage regulatory submissions and ethics committee documentation.
• Collaborate closely with sponsors and investigators to ensure smooth study operations.

Connaissances

Leadership

Communication

Problem Solving

Fluency in English

Description du poste

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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.

● Therapeutic Area: Hematology Gene Therapy

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]