Clinical Data Manager

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.

Position Details 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.

• Hands-On Study Execution: 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.
• External Data Reconciliation Workstream: 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.

For candidates based in the SFBA area, the salary range for this position is: $110,000 to $135,000. For candidates based outside the SFBA area, the salary range is 95,000 to 120,000. Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. 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.

• 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.

• 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. Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272. #LI-CD