Senior Manager, Clinical Research Operations

Senior Manager, Clinical Research Operations

Managers/Directors/Administrators

New York, NY

Full-Time/Regular

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.

At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.
For more information, go to med.nyu.edu , and interact with us on Linked In , Glassdoor , Indeed , Facebook , X and Instagram .

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.

Job Responsibilities:

• Performsupervisoryfunctionsfor operations managers, operations specialists,andsupportspecialistroles.
  
  Theserolesprovideforintakeand triage of clinical research submissions,andpreparationandapprovalofbudgets and payment terms.
  
  Themanagerwillensureworkloadequity,maintain consistency of processes, and perform day-to-day staff supervision, including hiring, performance management, and orientation.
• Collaborateandcoordinatewithleadershiptoensureofficeproceduresstayalignedtorelatedprocesseswithinthe continuum of the studylifecycle,e.g.,research finance,contracts,sponsored programs,billing compliance,IRB,etc Ensure quality and timeliness of team output.
• Serveastheprimaryliaisonbetweenthedepartmentinvestigatorandcentralofficeonallmattersofstudypre-award budget and payment terms processes, and maintain transparency regarding the status of the budget.
• Usingtheinternalbillinggridprospectivereimbursementanalysis,developsacompleteinternalbudgetassuringthatall research procedures, personnel, and administrative fees are accounted for.
• Comparescompletedinternalbudgetagainstsponsoroffer,andnegotiateswithsponsoruntilasatisfactory reimbursement schedule is obtained.
• Collaborates with OSR Contracts stafftoensurethefinalnegotiatedbudgetand payment termsareincorporatedintothe Final executable research agreement.
• Enters finalized budget and payment termsinto
  
  Clinical Research Management  System ,including appropriate visit descriptions and payments,invoicedseparatelyprocedures,optional procedures,subject stipend,andtraveltermsandother reimbursable items.
• Reviews study amendments for impact to budget and contract, and initiate those processes when necessary.
• Contributetothedevelopment,implementation,andongoingevaluationofstrategiesandprocessestoimproveoperations of the unit.
• Train and mentor other Operations Managers, and Operations and Support Specialists
• Initiate,develop,andnegotiatemasterratecardswith
  
  Industrysponsorsforadministrativefeesandstandardprocedures.
• Assist with NYU goal of reducing study startup timelines, by assisting (i) with developing ideas for process improvement, (ii) with implementing processes, and (iii) with monitoring key performance indicators (KPIs).
• Other duties as assigned.

Minimum Qualifications:

• Bachelor's Degree in Finance, Business Administration, Healthcare, related field, or equivalent in education and experience
• Five (5) or more years of experience developing and negotiating budgets and payment terms.
• Prior experience in clinical research and/or billing compliance required.
• Detail-oriented and a sense of ownership in work.
• Ability to manage time, multi-task, and prioritize work.
• Ability to communicate effectively through e-mails, in person, and by phone.
• Ability to interface effective with all levels of the organization.
• Prior experience supervising…