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.

Regulatory Study Start-Up Project Manager - 100% Home based

Job Description