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

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.