Clinical Trials Business Manager

Nemours is seeking a Clinical Trials Business Manager to join our Nemours Children's Health team in Wilmington, DE.

The Clinical Trials Business Manager is responsible for overseeing the operations and business practices for clinical research studies while ensuring compliance with federal, state, local and institutional guidelines. The incumbent actively remains current with industry standards, trends, and competitive intelligence on contracting best practices. The incumbent reviews clinical research protocols, agreements, and budgets; works with the Principal Investigator (PI) and the Research Study Coordinator to determine which protocol assessments are study specific and performs a cost analysis. In addition, the incumbent develops preliminary clinical research study budgets and works with the research, ancillary and clinical team members to ensure that all costs are captured. The Clinical Trial Contracts Manager is responsible for price negotiations and payment terms with industry and nonprofit sponsors. The Clinical Trial Business Manager will directly supervise the Clinical Trials Contracts Coordinator(s).

Essential Functions:

1. Responsible for all phases of clinical trials administration.
2. Ability to analyze clinical trial budgets and complex contracts and negotiate mutually satisfying terms and conditions.
3. Act as a liaison with Legal Department and sponsor to ensure applicable language inclusion in the clinical trial agreement
4. Review hospital and professional study related service fee schedule regularly to ensure study related costs are captured accurately and negotiate any conditional rates directly with the division.
5. Build study templates to efficiently capture study visits for sponsor invoicing and payment reconciliation.
6. Work closely with Research Study Coordinators to ensure study visits are being reported timely and accurately for billing purposes each month.
7. Work with the Accounting Department to provide general accounting support to Research Administration. The incumbent will provide back-up support to other Research Administration team members in the areas of Federal grants, Nemours-sponsored Protocols, Clinical Trials, Non-federal grants and perform other duties as needed.
8. Serve as a lead role in the CTMS implementation, maintenance and system updates.
9. Interact with PI's, Office of Sponsored Projects (OSP), Accounting and Research Administration (RA) staff to resolve moderately complex problems that cross-departmental lines to optimize the use of funds.
10. Serve as the single point of contact for clinical trials related activities, and works in collaboration with Office of Sponsored Projects staff as well as other departments.
11. Prepare clinical trials closeout functions according Nemours policy and as required by sponsors, including reconciliations, final invoices, study status reports (SSRs), and final reporting.

*These responsibilities are open to review and evaluation dependent upon the further growth and development of the Research Administrative team and Operational Vice President of Research.

Requirements:

Bachelor's Degree in Business, Finance or related field.

Minimum of 7 years of experience in Pre-Award or Post-Award Research Administration