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Fortrea

Assoc Project Manager , Start-up Sponsor-dedicated

Fortrea Paris, Ile-de-France, France

Biotechnology Research · 10,001+ employees

14 h ago
project-manager Senior (5-10 yrs) Full-time France
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About the role

Lead country-level regulatory submissions and approvals while ensuring compliance with ICH/GCP and local regulations. Manage cross-functional collaboration and oversee local vendors to ensure regulatory milestones are met.

What they look for

Clinical research Regulatory submissions EU-CTR ICH/GCP Regulatory compliance Project management Stakeholder engagement Informed consent forms Regulatory operations Mentoring Clinical trial protocols Vendor management

Requirements

Requires a minimum of 5 years of experience in clinical research, including at least 2.5 years in EU-CTR regulatory submissions. Candidates must hold a scientific background such as a Pharmacist or PhD degree and possess fluency in French and English.

Benefits

Competitive compensation Professional development Career progression Flexible working arrangements

Full description

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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