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

About the Opportunity

Location: Fully remote, based anywhere in ROI

Employment Type: Full-time, Client-Dedicated

Responsibilities

• 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

About You

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

Eligibility

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.

Benefits

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.

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