Assoc Project Manager , Start-up Sponsor-dedicated

Fortrea; Paris; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Flexible working arrangements

Résumé du poste

Fortrea in France is seeking a Start Up Country Lead to direct regulatory operations for clinical trials, ensuring compliance, quality, and timely delivery of study milestones in a global environment. Location: client’s office two days a week in a hybrid model with remote possibility.

The role requires minimum 5 years in clinical research, including EU-CTR regulatory submissions, and a scientific background (Pharmacist, PhD, or equivalent).

Qualifications

• 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.

Responsabilités

• Lead country-level regulatory submissions and approvals for trial protocols.
• Translate and manage local language materials, including informed consent forms.
• Liaise with IRB/IEC and Regulatory Authorities for compliance with ICH/GCP and local regulations.
• Manage country deliverables, timelines and results to meet study commitments.
• Collaborate with cross-functional teams to ensure regulatory milestones are met.
• Oversee local vendors and site staff to ensure regulatory processes are properly managed.
• Serve as SME in regulatory processes and contribute to SOP development and continuous improvement initiatives.

Formation

Pharmacist/PhD

Description du poste

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

Learn more about our EEO & Accommodations request here.