Clinical Research Associate Manager France
il y a 1 semaine
Job Description:
Fortrea, a leading global contract research organization, seeks a highly skilled Clinical Research Associate Manager to oversee the execution and approval of clinical trial country submissions in France. This role requires a strong understanding of clinical development, patient access, and technology solutions.
Key Responsibilities:
- Manage country submissions and approvals for assigned protocols, ensuring timely and compliant execution.
- Develop local language materials, including informed consents and translations, to meet regulatory requirements.
- Collaborate with IRB/IEC and Regulatory Authority for submission and approval-related interactions.
- Oversee country deliverables, timelines, and results to meet country commitments.
- Contribute to the development of local SOPs, ensuring compliance with regulatory standards.
- Work closely with Clinical country operations, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
- Collaborate with Regional Operations to align country timelines for assigned protocols.
- Provide support and oversight to local vendors as applicable.
- Assist with financial duties, including country and site budgets, and oversight of clinical research-related payments.
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enter and update country information in clinical, regulatory, safety, and finance systems.
Requirements:
A university degree, certification in a related allied health profession, or four or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting is required.
Fortrea is an Equal Opportunity Employer that strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
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