FMV Specialist

Role: Fair Market Value Specialist

Location: Remote (US-based preferred)

Hours: Full-time (40 hours/week)

Contract: 12 months with potential for extension

We're seeking a detail-oriented FMV & Budget Analyst to support our Global Clinical Trial Operations team. This role plays a key part in preparing fair market value analyses and clinical study budgets, ensuring alignment with regulatory standards and internal policies.

What You'll Do:

• Independently analyze study protocols to develop FMV assessments and site budgets using internal tools and databases.
• Prepare and distribute budget packages and negotiation documents to support site contracting.
• Track and manage budget requests across multiple studies and divisions, providing insights for future negotiations.
• Collaborate with study teams to prioritize budget reviews and maintain alignment with contracting timelines.
• Review site budget escalations and authorize exceptions beyond FMV when justified.
• Maintain budget data in Clinical Trial Management Systems (e.g., Siebel CTMS) and ensure documentation is complete and audit ready.
• Escalate risks and coordinate with leadership and stakeholders to resolve budget-related issues.
• Ensure compliance with ICH/GCP, FDA, IRB/EC regulations, and internal SOPs.

Minimum Requirements:

• Bachelor's degree in finance, Business, or equivalent experience.
• Minimum 2 years supporting clinical research, preferably in a sponsor or CRO setting.
• Experience with CTMS, eTMF systems, and working within SOP-driven environments.
• Strong multitasking skills and ability to manage competing priorities across studies.

Preferred:

• Experience supporting clinical sites across multiple regions
• Understanding of medical coding and diagnosis terminology
• Skilled in collaborating with diverse stakeholders across organizational levels
• Proficient in using Grants Manager for budget development.

If this role aligns with your expertise and interests, apply now!