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

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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 youll 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 youll play a pivotal role in study start-up - when precision and speed matter most.

What Youll 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 Youll 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.

Required Experience:

Location: Fully remote based anywhere in ROIEmployment Type: Full-time Client-DedicatedWe are seeking a Regulatory Study Start-Up Project Manager to join our this role you will work 100% dedicated to a leading global pharmaceutical company playing a critical part in the successful initiation of cli...