Clinical Data Manager
About The Position
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com. We are seeking a highly collaborative, meticulous, and hands-on Clinical Data Manager to drive the technical execution and documentation of clinical data management activities across our gene therapy clinical development programs. Reporting to the Senior Director of Clinical Data Management, this individual will provide critical, hands-on data management and validation support to senior Clinical Data Management leadership, enabling the department to strengthen strategic oversight and maintain inspection readiness. This is a highly technical, data- and documentation-heavy execution role, rather than a project management or site-facing Clinical Operations position. The successful candidate will be deeply involved in the day-to-day lifecycle of the data—from protocol review and UAT execution to complex external data reconciliation and cross-functional QC—ensuring our clinical databases are complete, accurate, and completely traceable for regulatory authorities. This role is well suited to a hands-on facilities professional with 4–6 years of experience who can independently manage day-to-day operations, coordinate vendors and contractors, and resolve routine issues within established guidelines.
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.
- Demonstrated ability to write and QC UAT plans and scripts while systematically archiving objective validation evidence.
- Solid understanding of GCP standards, CDISC standards (CDASH, SDTM), MedDRA/WHODRUG coding, and FDA/ICH guidelines.
- Exceptional organizational skills, an obsession with detail/accuracy, and a proactive approach to closing compliance gaps.
Nice To Haves
- Experience supporting gene therapy, rare disease, neurology, or cell therapy clinical programs.
- Experience with electronic patient reported outcomes.
- Experience with the review, reconciliation, and cleaning of neurodevelopmental, behavior, and motor assessments.
- Experience operating with in-house data management as well as managing outsourced CRO/vendor data management models.
- Familiarity with biomarker, genomic, imaging, longitudinal, or complex external datasets common within gene therapy development.
- Experience supporting global clinical studies, regulatory inspections, and submission activities preferred.
- Experience in an emerging biotechnology or growth-stage company environment preferred.
- Knowledge of CDISC SDTM/ADaM principles and clinical data standards preferred.
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.
- 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.
- 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.
- 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.
- Partner with Clinical and Biometrics to draft comprehensive Data Management Plans (DMPs), eCRF specifications, completion guidelines, and data transfer agreements.
- Manage technical deliverables and data flows from contracted CDM vendors, ensuring all activities meet strict corporate timelines and quality thresholds.
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
- Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan.
- Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave.
- Employees will also enjoy designated paid holidays throughout the calendar year.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
