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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 & technologiesGoogle 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