About this role
Location: Fully remote, based anywhere in ROI
Employment Type: Full-time, Client-Dedicated
We are seeking a Regulatory Study Start-Up Project Manager to join our team. In this role, you will work 100% dedicated to a leading global pharmaceutical company, playing a critical part in the successful initiation of clinical trials within ROI.
As a Regulatory SSU PM, you’ll be the engine behind timely and compliant regulatory submissions and approvals for clinical trials in ROI. From ethics committee interactions to ensuring local language materials and Informed Consents are submission-ready, you’ll play a pivotal role in study start-up - when precision and speed matter most.
What You'll Own:
- Local Submissions & Approvals
- Full ownership of clinical trial submissions to Ethics Committees and Regulatory Authorities
- Development of local language materials, including translated Informed Consents
- Serve as the point of contact for approval-related interactions
Country Oversight & Delivery
- Drive country-level timelines and deliverables to meet protocol goals
- Ensure compliance with local regulations, laws, and procedures
- Track research-related payments and oversee close-out reconciliation
Quality & Collaboration
- Partner cross-functionally with Clinical Operations, Regulatory, Legal, Finance, and more
- Interface with external vendors, IRBs/IECs, and regulatory bodies
- Contribute to local SOPs and process optimization
What You'll Bring:
- Strong expertise in local regulatory environments and submission processes
- Experience working with IRBs/IECs and Regulatory Authorities
- Skilled in contract and budget negotiation
- Ability to influence internal and external stakeholders without direct authority
- Detail-oriented mindset with a passion for timelines and compliance
🌐 Why Join Fortrea?
Be part of a global organization where innovation meets impact. At Fortrea, your local expertise powers global progress - helping bring life-changing therapies to patients around the world.
If you are a motivated professional with a strong background in study start-up activities, this role offers an excellent opportunity to make a meaningful impact in clinical research while working in a flexible, fully remote environment.
Learn more about our EEO & Accommodations request here.
Other facts
About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
What you'll do
- The Regulatory Study Start-Up Project Manager will oversee clinical trial submissions to Ethics Committees and Regulatory Authorities, ensuring compliance and timely approvals. This role involves driving country-level timelines and collaborating with various departments to optimize processes.
Ready to join Fortrea?
Take the next step in your career journey