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FSP Start Up Country Lead based in Paris region in France
il y a 3 semaines
Are you passionate about clinical research and regulatory excellence? Fortrea is seeking a Start Up Country Lead to join our team in France. This role offers a unique opportunity to lead regulatory operations for clinical trials, ensuring compliance, quality, and timely delivery of study milestones in a dynamic and global environment.
This is a sponsor-dedicated opportunity.
Location: client's office 2 days a week (hybrid model, remote possibility)
Please note this role is for upcoming future opportunities that may arise at Fortrea.Key Responsibilities
- Lead country-level regulatory submissions and approvals for assigned clinical trial protocols.
- Translate and manage local language materials, including informed consent forms.
- Liaise with IRB/IEC and Regulatory Authorities to ensure compliance with ICH/GCP and local regulations.
- Manage country deliverables, timelines, and results to meet study commitments.
- Collaborate with cross-functional teams (CRM, CRA, CTC, Finance, Legal) to ensure regulatory milestones are met.
- Oversee local vendors and site staff, ensuring regulatory processes are properly managed.
- Act as a subject matter expert in regulatory processes and contribute to SOP development and continuous improvement initiatives.
Candidate Profile
- Minimum 5 years of experience in clinical research, with at least 2.5 years in regulatory submissions within the EU-CTR environment.
- A scientific background (Pharmacist, PhD, or equivalent).
- Strong knowledge of regulatory frameworks, clinical trial agreements, and compliance standards.
- Fluency in French and professional proficiency in English.
- Excellent organizational, communication, and stakeholder engagement skills.
- Experience mentoring junior staff and contributing to team knowledge building.
What We Offer
- A collaborative and inclusive work culture.
- Opportunities for professional development and career progression.
- Competitive compensation and benefits.
- Flexible working arrangements (remote or office-based).
- The chance to contribute to life-changing research
Ready to Apply?
If you're ready to make a meaningful impact in clinical research and regulatory operations, we'd love to hear from you. Apply today and join a team that values innovation, integrity, and excellence.
Learn more about our EEO & Accommodations request here.
