Location: Hybrid working model, with occasional visits to the sponsor’s offices in Dublin
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.
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What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
