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

Requirements

• BS/BA and/or MS degree Bachelor's 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 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.

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