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!
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