Clinical Data Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the main, hands-on Data Manager for various clinical studies, overseeing the daily data flow, managing discrepancies, and conducting detailed data review activities.

• Take ownership or co-ownership of external data reconciliation as a standardized cross-study initiative. Reconcile intricate datasets from several external vendors with the EDC and internal systems; diligently track, document, and resolve discrepancies to create an easily auditable framework.

• Examine Tables, Figures, and Listings (TFL) specifications and listings to confirm they are thoroughly supported by the clinical data collected. Collaborate directly with statisticians to investigate documentation trails and proactively resolve data mismatches.

• Develop, validate, and implement 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.

• Create and validate system- and data-related documentation. Maintain an impeccably traceable audit trail—ensuring clear documentation of file storage, versioning, and presentation to systems or validation inspectors.

• Collaborate with Clinical and Biometrics teams to draft thorough Data Management Plans (DMPs), eCRF specifications, completion guidelines, and data transfer agreements.

• Oversee technical deliverables and data flows from contracted CDM vendors, ensuring all activities align with strict corporate timelines and quality standards.

⛳️ Requirements

• BS/BA or MS degree in a scientific, health-related, or computational discipline with 4+ years of direct, hands-on clinical data management experience (experience in an emerging biotech or growth-stage company is strongly preferred).

• Proven expertise in managing the tactical day-to-day lifecycle of clinical data, which includes extensive data cleaning, multi-vendor dataset reconciliation, and comprehensive documentation authoring.

• Strong technical knowledge of EDC systems (preferably Medrio and Medidata RAVE), database programming concepts, and data review tools.

• Experience in reviewing, reconciling, and cleaning complex external datasets (e.g., biomarker, genomic, imaging, longitudinal data) as well as neurodevelopmental, behavior, and motor assessments.

• Proven ability to write and validate UAT plans and scripts while systematically archiving objective validation evidence.

• Solid grasp of GCP standards, CDISC standards (CDASH, SDTM), MedDRA/WHODRUG coding, and FDA/ICH guidelines.

• Exceptional organizational skills, a keen attention to detail and accuracy, and a proactive approach to addressing 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

• Fully stocked kitchen

• Fitness center at our S. San Francisco location