Clinical Data Manager

Responsibilities

• Serve as the primary, hands-on Data Manager for multiple clinical studies, driving the daily data flow, performing discrepancy management, and conducting granular data review activities
• Own or co-own external data reconciliation as a standardized cross-study workstream. Reconcile complex datasets from multiple external vendors with the EDC and internal systems; meticulously track, document, and resolve discrepancies to ensure an easy-to-audit framework
• Biostatistics & TFL Collaboration: Review Tables, Figures, and Listings (TFL) specifications and listings to ensure they are fully supported by the clinical data collected. Partner directly with statisticians to investigate document trails and aggressively resolve data mismatches
• Rigor-Driven User Acceptance Testing: Write, QC, and execute User Acceptance Testing (UAT) plans and test scripts, specifically for databases, CRFs, and data review tools/systems. Capture and archive objective evidence during UAT to ensure compliance
• Systems-Level Inspection Readiness: Author and QC system- and data-related documentation. Maintain a flawlessly traceable audit trail—ensuring clear documentation of where files are stored, how they are versioned, and how they will present to a systems or validation inspector
• Core Data Deliverables: Partner with Clinical and Biometrics to draft comprehensive Data Management Plans (DMPs), eCRF specifications, completion guidelines, and data transfer agreements
• Vendor Support: Manage technical deliverables and data flows from contracted CDM vendors, ensuring all activities meet strict corporate timelines and quality thresholds

Requirements

• BS/BA or MS degree in a scientific, health-related, or computational field with 4+ years of direct, hands-on clinical data management experience (Emerging biotech or growth-stage company environment strongly preferred)
• Demonstrated expertise managing the tactical day-to-day lifecycle of clinical data, including extensive data cleaning, multi-vendor dataset reconciliation, and comprehensive documentation authoring
• Strong technical proficiency with EDC systems (Medrio and Medidata RAVE preferred), database programming concepts, and data review tools
• Experience with the review, reconciliation, and cleaning of complex external datasets (e.g., biomarker, genomic, imaging, longitudinal data) as well as neurodevelopmental, behavior, and motor assessments
• Solid understanding of GCP standards, CDISC standards (CDASH, SDTM), MedDRA/WHODRUG coding, and FDA/ICH guidelines
• Solid organizational skills, an obsession with detail/accuracy, and a proactive approach to closing compliance gaps

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Designated paid holidays throughout the calendar year