Assoc Project Manager , Start-up Sponsor-dedicated

About The Role

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

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Lead country-level regulatory submissions and approvals for assigned clinical trial protocols.
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Translate and manage local language materials, including informed consent forms.
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Liaise with IRB/IEC and Regulatory Authorities to ensure compliance with ICH/GCP and local regulations.
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Manage country deliverables, timelines, and results to meet study commitments.
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Collaborate with cross-functional teams (CRM, CRA, CTC, Finance, Legal) to ensure regulatory milestones are met.
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Oversee local vendors and site staff, ensuring regulatory processes are properly managed.
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Act as a subject matter expert in regulatory processes and contribute to SOP development and continuous improvement initiatives.
Candidate Profile
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Minimum 5 years of experience in clinical research, with at least 2.5 years in regulatory submissions within the EU-CTR environment.
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A scientific background (Pharmacist, PhD, or equivalent).
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Strong knowledge of regulatory frameworks, clinical trial agreements, and compliance standards.
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Fluency in French and professional proficiency in English.
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Excellent organizational, communication, and stakeholder engagement skills.
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Experience mentoring junior staff and contributing to team knowledge building.
What We Offer
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A collaborative and inclusive work culture.
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Opportunities for professional development and career progression.
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Competitive compensation and benefits.
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Flexible working arrangements (remote or office-based).
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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.