Clinical Data Manager

Encoded TherapeuticsHomeOur Science⟵ ⟵ Back OverviewGenetic Medicines Product EnginePipeline & Programs⟵ ⟵ Back OverviewPipelineClinical StudiesETX101 for Dravet SyndromeResearch AreasPublications & PresentationsPatientCommunity⟵ ⟵ Back OverviewPatient Community StoriesDravet SyndromePre-Approval Access StatementHealthcareProfessionalsAboutNews⟵ ⟵ Back OverviewPress ReleasesMedia KitCareersContact Terms of Use Privacy Policy Cookie Policy Social Media Guidelines Encoded Therapeutics Sorry, your browser doesn't support embedded videos. Careers ←   Back to Careers Clinical Data Manager Department: Clinical Operations Locations: United States Type: Full time 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. Responsibilities 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...