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: clients office 2 days a week (hybrid model remote possibility)
Please note this role is for upcoming future opportunities that may arise at Fortrea.
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
Ready to Apply
If youre ready to make a meaningful impact in clinical research and regulatory operations wed love to hear from you. Apply today and join a team that values innovation integrity and excellence.
#LI-Hybrid #LI-LC1
Learn more about our EEO & Accommodations request here.
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...
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: clients office 2 days a week (hybrid model remote possibility)
Please note this role is for upcoming future opportunities that may arise at Fortrea.
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
Ready to Apply
If youre ready to make a meaningful impact in clinical research and regulatory operations wed love to hear from you. Apply today and join a team that values innovation integrity and excellence.
#LI-Hybrid #LI-LC1
Learn more about our EEO & Accommodations request here.
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