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Advanced Therapies Data Manager

Advanced Therapies Data Manager

Shields Advanced TherapiesBoston, MA, US
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Job Description

Job Description

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.

Core Responsibilities

Data Management & Reporting

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

Quality & Outcomes Reporting

  • 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

    • Interdepartmental Collaboration

  • 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

    • Regulatory & Compliance Support

  • 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

    • Location

    Hybrid (New York- or Boston-Based & Remote)

    Credentials & 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

    • Compensation

  • Competitive base salary with bonus opportunity tied to quality / outcomes metrics.

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