Assoc Project Manager , Start-up Sponsor-dedicated

Fortrea; Paris; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Collaborative culture

Professional development

Competitive compensation

Flexible working arrangements

Résumé du poste

Fortrea seeks a Start Up Country Lead in France to drive regulatory operations for clinical trials, ensuring compliance, quality, and timely delivery of milestones in a dynamic, global environment.

The role is sponsor-dedicated with a hybrid work model, offering opportunities to lead regulatory submissions, manage cross-functional teams, and mentor junior staff while contributing to SOP development and continuous improvement initiatives.

Qualifications

• 5+ years in clinical research with 2.5+ years in EU-CTR regulatory submissions.
• Scientific background such as Pharmacist, PhD or equivalent.
• In-depth knowledge of regulatory frameworks, clinical trial agreements and compliance.
• Fluent in French with professional English proficiency.
• Strong organizational and communication skills; stakeholder engagement.
• Experience mentoring juniors and sharing knowledge.

Responsabilités

• Lead country-level regulatory submissions and approvals for trial protocols.
• Translate and manage local language materials, including ICFs.
• Liaise with IRB/IEC and Regulatory Authorities for ICH/GCP compliance.
• Manage country deliverables, timelines, and results to meet study commitments.
• Collaborate with cross-functional teams to meet regulatory milestones.
• Oversee local vendors and site staff; ensure regulatory processes are followed.
• Contribute to SOP development and continuous improvement initiatives.

Connaissances

Regulatory submissions

Clinical research

Regulatory knowledge

French & English

Stakeholder engagement

Mentoring

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