US-NJ, The Senior Specialist IIT and FMV Program (FMV) 221193BR-MZ
The Senior Specialist IIT and FMV Program (FMV)
East Hanover, NJ
Audit & Finance
The Senior Specialist FMV Program (FMV) is responsible for the program management of Fair Market Value (FMV) for Investigator Initiated Trials (IITs) and negotiation of IIT Agreements, specializing in Amendments, across US Oncology. The scope includes Medical Affairs, Early Development Strategy & Innovation (EDSI) and Global Oncology.
1. Expert knowledge of IITs and IIT budget cost elements to prepare FMV analysis for the CPP (Cost per Patient), procedures, site costs, clinical efforts, patient related invoiceables and administrative costs.
2. Subject Matter Experts (SME) on cost benchmarking and analysis for IIT studies including use of GrantPlan , historical data and other sources of cost data.
3. Independently negotiates and finalizes IIT Amendments with Academic and Community sites including budget negotiation.
4. Collaborate cross functionally with Novartis legal, Compliance, Regulatory and other internal groups to negotiate contract language changes.
5. Manage programs in support of US Oncology IIT portfolio to ensure consistency and compliance with contracting and FMV guidelines.
6. Develop and implement processes and tools to drive program and operational excellence through continuous improvement, standardization and management of processes and systems to support US Oncology IIT program.
7. Lead creation or revision of Working Practices to standardize practices and ensure operational consistency.
8. Collaborate with CPO QA to ensure remediation of any audit issues related to FMV program.
9. Ability to lead collaborations with clinical trial team, study start up groups, other internal stakeholders and investigational sites as required.
10. Build and manage relationships with cross-functional and cross-divisional collaboration partners including Global Oncology, US GenMeds Medical and other Novartis Business Units.
11. Candidate works independently to meet anticipated internal and external timelines.
12. Full knowledge and understanding of Oncology clinical research phase I-IV.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
BS/BA degree in business administration, legal, science, or related field, or equivalent on the job experience may be considered. English
Minimum 5+ years of experience in negotiating clinical contracts and budgets.
Superior negotiation skills.
Strong computer skills including spreadsheet applications. Strong analytical capabilities required with an understanding of medical/clinical pharmaceutical Development
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