Business Manager - NYU Langone Heart
About The Position
NYU Langone Heart maintains a robust portfolio of current and upcoming clinical trials across Cardiology and Cardiothoracic Surgery. The faculty are specialists in cardiology and cardiac surgery, dedicated to advancing patient access to innovative technology and investigational treatments through industry-sponsored research. The Clinical Research Finance Manager is responsible for managing the study activation of all clinical trials in the NYU Langone Heart portfolio. This position reports directly to NYU Langone Heart Directors with OSR support, and works closely with Principal Investigators (PIs), Research teams, Industry Sponsors, CROs, and departmental administrative staff. The Clinical Research Finance Manger will also work closely with OSR units including Clinical Research Support Unit (CRSU), OSR-Contracts, and Institutional Review Board (IRB). The overall goal of this position is to manage budget development, negotiation, and billing terms to ensure clinical trial fiscal sustainability and facilitate efficient clinical trial activation processes.
Requirements
- Bachelors degree required. Preferred in accounting, finance, or healthcare-related field.
- Three or more years experience developing and negotiating budgets, clinical research, and/or billing compliance.
- Working understanding of research billing compliance, including National Coverage Determinations (NCCDs) for coverage of routine costs and the CMS Research policies.
- Strong familiarity with budget development, coverage analysis, and experience with budget negotiation.
- Qualified candidates must be able to effectively communicate with all levels of the organization.
Nice To Haves
- Masters Degree preferred (MBA, Clinical Research, or related degree).
- Experience working on industry-sponsored clinical trials highly desired.
- Prior experience supporting clinical trial processes and/or working on clinical trials budgets/contracts supporting industry-funded clinical trial protocols investigating drugs/devices for treating cardiology/cardiothoracic related conditions.
- PMP a plus.
Responsibilities
- Build internal billing grid, internal budget, and prospective reimbursement analysis ensuring all research procedures, study subjects, personnel, and administrative fees are accounted for. Apply appropriate inflation and margin rates.
- Review industry budget proposals against internal budget and negotiate directly with sponsor and/or Clinical Research Organization (CRO), with input from the research team, until a satisfactory budget is attained.
- Oversight over all NYU Langone Heart industry-sponsored clinical trial budget development in accordance with study protocol and market rates, negotiating fees as applicable, during study activation and amendment/modification approval processes.
- Manage study activation for NYU Langone Heart industry-sponsored studies by managing and leading team meetings across OSR and NYU Langone Heart to identify any potential bottlenecks and track related turnaround times for contracting, budget finalization, and IRB approval.
- Authorized to coordinate escalation processes on behalf of OSR and Research teams.
- Responsible for managing OSR escalation plan(s) with a detailed focus and aim to identify and resolve potential roadblocks that may affect study activation.
- Follow OSR workflows, guidance, and best practices for study activation and approvals for amendments/modifications.
- Collaborate with Sponsored Projects staff to ensure final negotiated budget and billing terms are incorporated into executed Clinical Trial Agreement.
- Enter sponsor invoicing terms into Clinical Research Management system including appropriate visit descriptions and payments, separately invoiced procedures, optional procedures, subject stipend and travel reimbursement terms, and other reimbursable and/or invoiceable items.
- Collaborate with Research Finance to load budgets into PeopleSoft and create the chart string.
- Review study amendments for impact to budget and contract. Initiate review process when applicable.
- Maintain thorough communication and transparency with Study teams throughout study activation and post-activation amendments.
- Provide updates to NYU Langone Heart leadership on progress of all new industry studies and related amendments.
- Other duties as assigned.
Benefits
- financial security benefits
- a generous time-off program
- employee resources groups for peer support
- holistic employee wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
