Clinical Data Manager

🔥 6 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $95k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📊 Data Scientist

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Encoded Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Encoded Therapeutics Inc. is a biotechnology company focused on developing innovative genetic medicines to address central nervous system (CNS) disorders. Their work aims to tackle the root causes of these disorders, providing potentially transformative, long-lasting therapies designed to improve patient outcomes and quality of life, particularly for conditions such as Dravet Syndrome and Angelman Syndrome. The company uses a unique targeting and regulation platform allowing for increased gene specificity and cell selectivity, overcoming challenges associated with first-generation gene therapies. Encoded Therapeutics is dedicated to translating cutting-edge science into practical, life-changing solutions for patients worldwide.

📋 Description

• 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.

🎯 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.

🏖️ 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