PROGRAM MANAGER – Transplant and Cellular Therapy

SUMMARY OF RESPONSIBILITIES:

• Administers all aspects of the Transplant and Cellular Therapy (TCT) Program in accordance with certification requirements by the Foundation for Accreditation of Cellular Therapy (FACT), FDA, and other regulatory agencies. Includes administration or requirements in the outpatient, inpatient, infusion, lab and apheresis settings.
• Partners with other hospital leaders and teams in these areas to ensure compliance to regulatory standards.
• Oversees the creation, review, approval, and implementation of all quality management policies and procedures.
• Ensures that all quality management policy procedures follow FACT standards and all applicable state and government laws and regulations prior to implementation.
• Oversees periodic reviews and audits of clinical program activities to ensure continued compliance with all written SOPs and policies.
• Manages federally mandated data reporting to the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP).
• Ensures all reporting deadlines are met.
• Oversees and assists TCT clinical teams to submit required IRB and Advocate Health clinical research submissions and approvals.
• Oversees the TCT financial team in the development of managed care contracts with third party payors.
• Oversees the preparation and annual reporting of programmatic data to third party payors to maintain contracts.
• Maintains Universal Procedure of Interactions (UPOIs) with contracted donor centers to maintain recognition as an NMDP Apheresis and Marrow Collection center.
• Manages all stem cell collections via apheresis and marrow harvest.
• Meets quarterly with NMDP leaders to review product data to ensure we are providing the highest quality product and discuss strategies for improvement.
• Responsible for human resources duties, including recruiting new employees, promotions, staff professional development, performance evaluations, compensation, resolution of employee concerns, corrective disciplinary actions, terminations, and overall employee morale.
• Develops and recommends operating and capital budgets and controls expenditures within approved budget objectives.
• Responsible for understanding and adhering to Advocate Health’s Code of Ethical Conduct, and ensured personal actions, and the actions of employees supervised, comply with the policies, regulations, and laws applicable to the organization's business.

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