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Assoc Project Manager , Start-up Sponsor-dedicated

Fortrea
Posted 3 hours ago
FranceHybridOperations & Admin
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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)

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.

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