Senior Manager Clinical Research Operations

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care.

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We have an exciting opportunity to join our team as a Senior Manager, Clinical Research Operations.

The Clinical Research Support Unit (CRSU), part of the Industry Clinical Research Unit (ICRU) at NYU Langone Health, oversees the pre-award financial administration of Clinical Research studies, including assessment of studies, preparing internal budgets, negotiation of budgets and payment terms with industry entities, and ensuring compliance with relevant federal regulations and institutional policies. ICRU is seeking a Senior Manager to provide operational oversight and leadership for the CRSU.

This is a high-performance position that requires meeting deadlines both internal to the organization, and external supporting agencies.

• Perform supervisory functions for operations managers, operations specialists, and support specialist roles. These roles provide for intake and triage of clinical research submissions, and preparation and approval of budgets and payment terms. The manager will ensure workload equity, maintain consistency of processes, and perform day-to-day staff supervision, including hiring, performance management, and orientation.
• Collaborate and coordinate with leadership to ensure office procedures stay aligned to related processes within the continuum of the study life cycle, e.g., research finance, contracts, sponsored programs, billing compliance, IRB, etc Ensure quality and timeliness of team output.
• Serve as the primary liaison between the department investigator and central office on all matters of study pre-award budget and payment terms processes, and maintain transparency regarding the status of the budget.
• Using the internal billing grid prospective reimbursement analysis, develops a complete internal budget assuring that all research procedures, personnel, and administrative fees are accounted for.
• Compares completed internal budget against sponsor offer, and negotiates with sponsor until a satisfactory reimbursement schedule is obtained.
• Collaborates with OSR Contracts staff to ensure the final negotiated budget and payment terms are incorporated into the Final executable research agreement.
• Enters finalized budget and payment terms into Clinical Research Management System, including appropriate visit descriptions and payments, invoiced separately procedures, optional procedures, subject stipend, and travel terms and other reimbursable items.
• Reviews study amendments for impact to budget and contract, and initiate those processes when necessary.
• Contribute to the development, implementation, and ongoing evaluation of strategies and processes to improve operations of the unit.
• Train and mentor other Operations Managers, and Operations and Support Specialists
• Initiate, develop, and negotiate master rate cards with Industry sponsors for administrative fees and standard procedures.
• Assist with NYU…