Korro Bio, Inc.

Data Scientist

• Lead clinical data management activities across one or more global studies/programs
• Deliver high-quality, audit-ready clinical trial data supporting regulatory submissions and clinical development timelines
• Serve as the primary data management point of contact for assigned studies/programs
• Oversee CRO and vendor performance, database design, and data cleaning strategy from study start-up through database lock and archival
• Produce high-quality databases on time and within study budget
• Present data and documentation supporting regulatory requirements
• Author, review, and maintain data management policies, SOPs, work instructions, job aids, and training documents
• Serve as the clinical data management subject matter expert for internal and external teams
• Provide expertise in electronic data capture, external data standardization, data collection and processing, and creation of data collection forms and validation checks
• Collaborate with Clinical Development, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory, Translational Research, and Clinical Operations
• Contribute to study protocols, SAPs, and other clinical documents; map data flows, processes, and systems
• Deliver Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, and Lab Specifications
• Oversee EDC and clinical data system builds, vendor UATs, database migrations, and mid-study updates
• Establish external data transfer guidelines and reconcile electronic transfers from CROs and vendors
• Oversee CRO data cleaning, query processing, ongoing data review, and tracking of data issues and trends
• Coordinate data metrics, trending, and reports for data review meetings and assist with listings and specifications for statistical review and audits
• Ensure compliance with national and international regulatory guidelines
• Support study close-out audits and contribute to departmental process and standards development
• Manage delivery of studies against budget

Associate Director, Data Manager

Clinical Research

• Plan, drive, and oversee all aspects of multicenter global clinical trials in compliance with GCPs, SOPs, designated budgets, and timelines
• Drive implementation of clinical operational strategy for assigned clinical studies
• Optimize trial design and execution and collaborate with study teams to accelerate clinical trial timelines
• Manage CROs and vendors, including contracting and clinical budgets
• Develop contingency plans for clinical trials
• Coordinate and lead study team meetings and update the Program Team on timelines and milestones
• Contribute to study documentation, including protocol review, study plans, ICFs, and CRF design
• Participate in CRO/vendor identification, qualification, and selection
• Participate in site selection; review consent forms; track patient accrual and study progress; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting
• Oversee clinical monitoring from site qualification through site closure
• Assure clinical data integrity through review of case report forms, source documents, and medical records
• Evaluate and analyze clinical data
• Oversee CRO delivery of studies in alignment with timelines and budgets
• Establish transparent communication, clear goals, and risk-based oversight
• Ensure compliance with internal policies, GCPs, and applicable regulations; maintain inspection readiness
• Oversee vendor contracts and clinical study budgets; report progress to Finance
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
• Oversee TMF management and review TMF documentation
• Travel to field sites as needed, under 25%

Associate Director, Data Manager

Senior Clinical Trial Manager