Manager Clinical Program Quality - BMT Cell Therapy

Under the direction of the Program Director, responsible for all data and analytic efforts to support TGH’s objectives in improving hospital quality and safety. Responsible for the data integrity, reporting, auditing, policy development, and accreditation for the program. Prepares for and participates in audits and inspections conducted by various cooperative groups and regulatory bodies. Coordinates and manages data collection, and prepares reports using established protocols.

Essential Functions:

• Manages the Center for International Blood and Marrow Transplant Research (CIBMTR) and National Marrow Donor Program (NMDP) data registries, and updates in real time
• Assists in creating and illustrating quality improvement and compliance measures
• Manages Cellular Therapies (Bone Marrow Transplant and CAR T-cell) and Cancer Center data collection and prepares reports using established protocols, related to outcomes to internal and external agencies, including to international registries

• Manages and updates the internal Cellular Therapy EMR system.

• Maintains and updates important master lists and distribute them to internal and external agencies, which may include preparing data presentations

• Develops and updates data capture forms, to be submitted to regulatory agencies, manufacturers, and insurers in a timely fashion

• Trains, develops, and oversees data and quality team members
• Mandatory participation in ten annual hours of educational activities related to transplantation and cellular therapy and quality management, including activities related to transplantation
• Perform quality audits for all components of the program
• Support the accreditation of Foundation for the Accreditation of Cellular Therapy (FACT), and coordinate regulatory data audits
• Support the analysis and organization of qualitative clinical, financial, operational, and administrative data
• Responsible for entering and querying BMT-related data
• Participate in process improvement initiatives when necessary