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Korro Bio, Inc.

Associate Director, Data Manager

Korro Bio, Inc.

. Lead clinical data management activities across one or more global studies/programs .

Posted 9/25/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $185,000 - $220,000 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud PlatformVault

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred
  • Minimum of 8 years of progressive experience in clinical data management/clinical trials, including late-stage and/or registration-enabling trials across Phase I–IV
  • Experience managing CRO relationships and overseeing outsourced clinical data management activities
  • Ability to lead cross-functional teams and manage CRO performance without direct reporting authority
  • Proficiency in EDC platforms, including Medidata Rave, Veeva Vault EDC, and Zetla
  • Experience with data cleaning, query management, discrepancy resolution, and database lock processes
  • Experience with complex study designs and matrix management of vendors
  • Proficiency with data aggregation, data visualization and analytics, risk-based monitoring, automated data bots, and machine learning/AI-based process enhancements
  • Knowledge of FDA, EMEA, ICH, GCP, and CDISC standards, including CDASH, SDTM, and ADaM
  • Knowledge of medical terminology and coding dictionaries, including MedDRA and WHODrug
  • Excellent written, oral, interpersonal, analytical, and risk mitigation skills
  • Ability to work independently and collaboratively, manage multiple projects, and contribute to internal data management policies and initiatives
  • Ability to attend meetings across different global time zones
  • Alignment with Korro's core values

Benefits

Comp & perks
  • Equity-based compensation
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) retirement plan
  • Life insurance
  • Dependent care flexible spending account
  • Company-funded health savings account
  • Free parking