Acceptance Testing, Biometrics, Biostatistics, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Data Management, Clinical Support, Clinical Trial, Contract Research Organization (CRO), Cross-Functional, Data Cleaning, Data Collection, Data Management, Data Quality, Database Programming, Detail Oriented, Disease, Documentation, Drug Development, Gene Therapy, Genetic Diseases, Genomics, Medical Products, Monitor Regulations, Pharmacovigilance, Problem Solving Skills, Reconciliation, Regulatory Submissions, Scripting (Scripting Languages), Startup, Team Player, Time Management
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 collaborative, detail-oriented, and scientifically driven Clinical Data Manager to support the planning, execution, and oversight of clinical data management activities across our gene therapy clinical development programs. Reporting to the Senior Director of Clinical Data Management, this individual will partner cross-functionally with Clinical Operations, Biostatistics, Medical Monitoring, Regulatory Affairs, Pharmacovigilance, Quality, and external CROs/vendors to ensure delivery of high-quality, reliable, and inspection-ready clinical trial data.
The Clinical Data Manager will oversee data management activities across one or more clinical studies or workstreams, supporting study startup, database development, data cleaning, reconciliation, reporting, database lock, and regulatory submission readiness activities. The Clinical Data Manager will ensure the accuracy, consistency, completeness, and high quality of the clinical data.
The ideal candidate is a proactive problem solver who thrives in a fast-paced biotech environment and is passionate about supporting transformative therapies for patients with serious diseases.
Responsibilities
- Serve as the Clinical Data Manager for assigned studies and/or lead specific, specialized data management workstreams (e.g., manual data review, external vendor data management) across multiple studies within a clinical program
- Participate in protocol and amendment reviews of assigned studies or program workstreams to ensure optimal CRF design and cross-study data standardization
- Partner with Clinical and Biometrics to develop or contribute to comprehensive Data Management Plans and Data Review Plans, covering all aspects of data collection, processing, reconciliation, review, and archival for the assigned scope
- Lead or support the design and build of the clinical databases and review tools to ensure they support clinical study objectives
- Responsible for user acceptance testing (UAT) within assigned study scopes or workstreams, including authoring and/or executing scripts
- Oversee or execute assigned aspects of data collection and review, which may include: monitoring data flow, performing discrepancy management, leading and participating in data review or reconciliation activities, and planning/facilitating database lock
- Manage timelines for assigned CDM activities to support corporate and clinical program objectives.
- Ensure complete, accurate and inspection-ready CDM documentation within the assigned scope
- Ensure all CDM documentation are complete, accurate and inspection-ready state.
- Act as team SME for key data systems and data streams, and process enhancement efforts
- Contribute to program deliverable timeline creation
- Performs additional duties as assigned
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Encoded Therapeutics Inc