CORE COMPETENCIES
Clinical Trial Contracting and Negotiation Regulatory Compliance (FDA, DOH, HIPAA, AKS, FCA, STARK) Intellectual Property and Data Rights Risk Assessment and Mitigation Contract Lifecycle Management (OnCore, Meditract, Huron) Policy Development and Process Improvement Cross-Functional Collaboration Team Leadership and Training Master Agreements (CTA, CDA, DUA, Subcontracts, Consortium Agreements, Collaboration Agreements) Stakeholder Engagement and Escalation Management
PROFESSIONAL EXPERIENCE
Icahn School of Medicine at Mount Sinai – New York, NY Grants and Contracts Manager • July 2024–Present Lead a team of Senior Contract Specialists supporting Oncology, Dermatology, Medicine, Emergency Medicine, Pediatrics, and Anesthesiology. Partner with senior leadership to implement policies, streamline operations, and strengthen institutional contracting practices. • Manage team workload, training, and performance to ensure consistent application of institutional standards • Serve as senior escalation point for complex negotiations, regulatory interpretation, and institutional risk issues • Collaborate with Legal, Compliance, Technology Transfer, and clinical departments to align contracting practices with institutional priorities • Project Manager for implementation of an AI-driven contract review tool to improve efficiency and consistency • Present regularly at the Clinical Research Coordinator Bootcamp on contracting fundamentals and risk considerations
Senior Grants and Contracts Specialist • March 2021–June 2024 Negotiated and drafted clinical trial agreements, site agreements, indemnification terms, ARO agreements, investigator-initiated agreements, and related research contracts with pharmaceutical sponsors, CROs, and academic institutions. • Conducted comprehensive risk analyses for clinical studies, protecting institutional and investigator interests • Negotiated contract terms ensuring compliance with DOH, FDA, STARK, Sunshine Act, Anti-Kickback Statute, False Claims Act, and HIPAA • Coordinated with Mount Sinai Innovation Partners (MSIP) on intellectual property, data rights, and technology transfer considerations • Managed contract lifecycle using Meditract, OnCore, and Huron, ensuring timely execution and audit-ready documentation • Served as primary point of contact for amendments, notices, and sponsor communications • Collaborated with clinical departments to support study activation and operational readiness
Additional Institutional Contracting Experience
• Negotiated Master Clinical Trial Agreements, Master CDAs, Data Use Agreements, Participation Agreements, Subcontracts, Consortium Agreements, and Collaboration Agreements for large-scale research initiatives • Drafted contract amendments and CDAs for complex research programs and discovery-focused units • Partnered with General Counsel, Export Control, Risk Management, and Digital and Technology Services to resolve high-risk contract issues • Trained and onboarded new contract specialists, reinforcing best practices and institutional standards
Speaking Engagements
• MAGI Boston (May 2022): Introduction to Clinical Trial Contracts – Part 1
• MAGI@Home (October 2024): Introduction to Clinical Trial Contracts – Part 2
Law Offices of James C. Mantia, P.C. – New York, NY Principal Attorney • April 2014–March 2021 Founded and managed a multi-practice litigation and transactional firm handling commercial litigation, real estate disputes, construction litigation, foreclosure defense, bankruptcy, ADA and Fair Housing matters, and complex real estate transactions.
Sperber Denenberg & Kahan, P.C. – New York, NY Associate Attorney • June 2008–March 2014 Handled litigation from inception through trial across bankruptcy, real estate, commercial disputes, class actions, and emergency injunctive matters.
Chestnut Holdings of New York, Inc. – Bronx, NY General Counsel • January 2007–June 2008 Built and led the company’s first in-house legal department. Oversaw litigation, contract development, lease drafting, and legal strategy for a large real estate portfolio.
Borah, Goldstein, Altschuler, Schwartz & Nahins, P.C. – New York, NY Associate Attorney • August 2000–December 2006 Litigation and transactional practice including trials, hearings, depositions, settlements, and contract drafting.
EDUCATION AND ADMISSIONS
Brooklyn Law School – Brooklyn, NY Juris Doctor, 2000 Stephan Jay Penzick Memorial Award for Administrative Law CALI Excellence Award for Administrative Law Intellectual Property Association
St. John’s University – Jamaica, NY B.A., Government and Politics, 1997 Dean’s List
Admissions
New York (2001)
U.S. District Court, Southern District of New York (2001)
U.S. District Court, Eastern District of New York (2001)