Assoc Project Manager , Start-up Sponsor-dedicated
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What you'll do
- 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.
What they're looking for
- 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 .
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.
Company
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