Advanced Therapies Data Manager
About The Position
About Shields Advanced Therapies Shields Advanced Therapies partners with health systems to accelerate advanced therapy access and operations, ensuring lifechanging breakthroughs reach more patients. Our management services and technology solutions serve as a horizontal support hub to empower health system-led, world-class advanced therapy care across 50+ disease states. Launched in September 2024, Shields Advanced Therapies is anchored by partnerships with four of the Top 20 Academic Medical Centers in the United States. Additionally, Shields' track record partnering with over 1,000 hospitals across 43 states in prior ventures provides a national channel for expansion. Role Overview The Advanced Therapies Data Manager is responsible for the accurate and timely collection, management, and reporting of data related to hematopoietic cell transplantation (HCT), cellular therapy, and gene therapy patients. This includes maintaining compliance with CIBMTR reporting requirements and supporting internal and external quality assurance initiatives. The Data Manager collaborates closely with clinical teams, quality staff, research coordinators, and regulatory agencies to ensure data integrity and support outcomes tracking and continuous improvement efforts.
Requirements
- Bachelor's degree in Health Information Management, Life Sciences, Nursing, Public Health, or related field
- 2-4 years of experience in clinical data management, preferably in transplant, oncology, or cellular therapy settings
- Familiarity with CIBMTR reporting tools (e.g., FormsNet3, AGNIS)
- Strong attention to detail and organizational skills
- Proficiency in EHR systems (e.g., Epic), Excel, REDCap, or data management platforms
Responsibilities
- Abstract, enter, and maintain clinical data in accordance with CIBMTR forms and submission timelines
- Prepare and submit data for transplant, cellular therapy, and gene therapy cases to national registries (e.g., CIBMTR, FACT, NMDP)
- Ensure data completeness and accuracy through chart review, EHR queries, and collaboration with clinical teams
- Participate in CIBMTR audit preparation and respond to data queries and discrepancies
- Develop, track, and analyze key quality metrics related to transplant, cellular therapy, and gene therapy outcomes
- Provide regular reporting to clinical leadership, the BMT/CAR-T Quality Committees, and other stakeholders
- Support FACT accreditation efforts through documentation of quality indicators and participation in continuous quality improvement (CQI) activities
- Contribute to survival analysis, engraftment trends, treatment toxicities, and other clinical outcome metrics
- Partner with physicians, nurses, quality officers, and research staff to ensure alignment of data and quality reporting goals
- Serve as the primary liaison to CIBMTR for data-related inquiries and audit preparation
- Work with informatics and IT teams to optimize EHR data extraction and reporting automation
- Maintain understanding of CIBMTR protocols, FACT standards, and GCP/21 CFR Part 11 as applicable
- Assist with regulatory reporting for IND protocols and post-market surveillance for FDA-approved cell/gene therapies
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
