Clinical Start-Up Specialist | Remote/Hybrid Growth

Fortrea; Paris; Hybride; EUR 52 000 - 76 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Remote/hybrid options

Career growth

Résumé du poste

Fortrea is seeking a Site Start-Up Specialist in Paris to coordinate site start-up activities and manage regulatory submissions. You will ensure compliant, audit-ready documentation and timely submissions for regulatory authorities and ethics committees.

The role involves collaboration with sponsor teams, vendors, and clinical staff, with responsibilities spanning document management, contract support, and training of colleagues.

Qualifications

• University/college degree in life sciences or related allied health field.
• Experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines and start-up processes.

Responsabilités

• Serve as the primary contact for investigative sites during start-up and maintenance.
• Collect, review, and organize documents for regulatory submissions (EC/IRB/Third Body/RA).
• Ensure compliance with ICH/GCP and sponsor requirements.
• Prepare and submit regulatory documents and informed consent forms.
• Track submission timelines and address delays proactively.
• Collaborate with internal/external stakeholders including vendors and authorities.
• Keep documentation audit-ready and systems updated.
• Assist in site contracts and budgets negotiation, if applicable.
• Provide mentorship and training to new hires.

Connaissances

Regulatory submissions

IRB/EC knowledge

ICH/GCP knowledge

Documentation management

Microsoft Office

Formation

Bachelor's or equivalent in life sciences

Outils

Document management systems

Description du poste

Fortrea is seeking a Site Start-Up Specialist in Paris to coordinate site start-up activities and manage regulatory submissions. You will ensure compliant, audit-ready documentation and timely submissions for regulatory authorities and ethics committees.

The role involves collaboration with sponsor teams, vendors, and clinical staff, with responsibilities spanning document management, contract support, and training of colleagues.