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. 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. 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. Perform additional duties as assigned. Requirements BS/BA and/or MS degree or equivalent combination of education/experience in science or health‑related field with 4 years of direct data management experience (rare disease experience highly desirable). Strong knowledge of CDM processes, EDC systems (Medrio and Medidata RAVE preferably), database programming, and quality management. Understanding of the MedDRA and WHODRUG coding processes. Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices. Outstanding problem‑solving abilities and influencing/negotiation skills. Excellent interpersonal, communication, and leadership skills. Logical thinking, attention to detail and accuracy, good organizational skills, and problem‑solving abilities. Ability to prioritize and adapt quickly to changing business conditions with a positive attitude. Willing to travel if required. Preferred Qualifications 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. 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. Employees (and their families) may obtain medical, dental, vision, and basic life insurance benefits through the company and enroll in our company’s 401(k) 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 View phone number on click.appcast.io. #J-18808-Ljbffr Encoded Therapeutics Inc.