Assoc Project Manager , Start-up Sponsor-dedicated

FTFRA Fortrea France SARL; Paris; Hybride; EUR 100 000 - 130 000; Plein temps

Avantages offerts par ce poste

Collaborative culture

Career development

Flexible schedule

Competitive compensation

Résumé du poste

Fortrea is seeking a Start Up Country Lead to guide regulatory operations for clinical trials in France. The role focuses on leading country submissions, ensuring compliance with ICH/GCP, and managing milestones in a hybrid setting with some remote work.

The ideal candidate has 5+ years in clinical research with EU-CTR submissions, a scientific background (Pharmacist/PhD), and fluency in French and English. Strong organizational and mentoring skills are required.

Qualifications

• Minimum 5 years in clinical research with EU-CTR submissions.
• Scientific background (Pharmacist or PhD) and regulatory knowledge.
• Fluent French and professional English.
• Excellent organization and stakeholder skills.
• Experience mentoring junior staff.

Responsabilités

• Lead country-level regulatory submissions and approvals for trials.
• Translate and manage local language materials including ICFs.
• Liaise with IRB/IEC and Regulatory Authorities for compliance.
• Manage country deliverables, timelines and study commitments.
• Collaborate with CRM, CRA, CTC, Finance, Legal to meet milestones.
• Oversee local vendors and site staff, ensuring regulatory processes.
• Contribute as SME and help develop SOPs and improvements.

Connaissances

Regulatory submissions

Stakeholder engagement

Project management

EU-CTR knowledge

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

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.