Assoc Project Manager , Start-up Sponsor-dedicated
PharmaCRO
Job 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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