Start-Up Specialist

Fortrea; Paris; Hybride; EUR 54 000 - 74 000; Plein temps

Avantages offerts par ce poste

Competitive salary and incentives

Flexible remote/hybrid options

Professional growth in a collaborative

Résumé du poste

Fortrea is seeking a Site Start-Up Specialist to coordinate site start-up activities, manage essential documents, and ensure regulatory submissions are completed efficiently.

You will work with the FSPx team and sponsor to advance development of cutting-edge medications, while maintaining audit-ready documentation and adherence to ICH/GCP guidelines.

Qualifications

• University/College degree (life sciences preferred) or certification in a related allied health profession.
• Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
• Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.

Responsabilités

• Serve as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is audit-ready and systems are consistently updated.
• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

Connaissances

Organizational skills

Communication skills

Problem solving

Formation

Life sciences degree

Outils

Microsoft Office

Document management systems

Description du poste

Join Our Team and Drive Clinical Research Success!

At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.

In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.

Key Responsibilities:

• Serve as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is audit-ready and systems are consistently updated.
• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

Required Qualifications:

• University/College degree (life sciences preferred) or certification in a related allied health profession.
• Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
• Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

What We Offer:

• Competitive salary and performance-based incentives.
• Flexible work arrangements (remote/hybrid options).
• Professional growth opportunities in a collaborative and innovative environment.
• The opportunity to work on cutting-edge clinical research projects.

Ready to Make an Impact?

Join us in shaping the future of clinical research.

EEO & Accommodations request here.