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Korro Bio is a biopharmaceutical company developing a new class of genetic medicines using a proprietary RNA editing platform. The company focuses on creating precise, transient single base edits to treat both rare and highly prevalent diseases, leveraging oligonucleotide-based approaches with established regulatory pathways.
As Associate Director of Clinical Data Management, you will report to the Director of Clinical Data Management and lead clinical data management activities across one or more global studies and programs. You will be the primary data management point of contact for assigned studies, ensuring timely delivery of high-quality, audit-ready clinical trial data in support of regulatory submissions and clinical development timelines.
Key responsibilities include:
- Delivering all data management tasks for assigned global studies from start-up through database closure and archival, producing high-quality databases for analysis and regulatory submissions on time and within budget.
- Demonstrating deep expertise in regulated environments, presenting data and documentation to support regulatory requirements.
- Authoring, reviewing, and maintaining data management policies, SOPs, work instructions, and training documents.
- Serving as the clinical data management subject matter expert, providing guidance on electronic data capture, external data standardization, and data collection processes.
- Working closely with cross-functional teams including Clinical Development, Biostatisticians, Statistical Programmers, Pharmacovigilance, Regulatory, and Clinical Operations.
- Providing input into study protocols, Statistical Analysis Plans, and clinical documents to ensure quality data collection.
- Overseeing EDC and clinical data system builds, including vendor UATs and managing mid-study updates.
- Establishing data transfer guidelines for external data and reconciling electronic data transfers from external vendors.
- Overseeing CRO data cleaning activities, processing queries, and identifying data issues and trends.
- Coordinating with CRO on data metrics, trending, and reports for internal stakeholder review meetings.
- Ensuring data system compliance with national and international regulatory authority guidelines.
- Supporting close-out audits and contributing to departmental process and standards development.
- Maintaining in-depth understanding of regulatory guidance including ICH, GCDMP, and 21 CFR Part 11.
You must have excellent written and oral communication skills, strong interpersonal abilities, and the capacity to build relationships, analyze complex issues, and resolve and mitigate risks. You should thrive in a small, fast-paced, innovative environment and have flexibility to attend meetings in different global time zones.
REQUIREMENTS:
- Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.
- Minimum 8 years of progressive experience in clinical data management and clinical trials, including late-stage and/or registration-enabling trials across Phase I–IV.
- Prior experience managing CRO relationships and overseeing outsourced CDM activities, ensuring adherence to project timelines, quality standards, and contractual deliverables; proven ability to lead cross-functional teams and manage CRO performance without direct reporting authority.
- Proficiency in EDC platforms (e.g., Medidata Rave, Veeva Vault EDC, Zetla), data cleaning, query management, discrepancy resolution, and database lock processes; experience with complex study designs and matrix management of vendors across studies and programs.
- Proficiency with current and evolving data management technologies including data aggregating, data visualization and analytics, risk-based monitoring (RBM), automated data bots, and machine learning/AI-based process enhancements.
- Knowledge of industry and regulatory standards (FDA, EMEA, ICH, GCP) and CDISC standards (CDASH/SDTM/ADaM); knowledge of medical terminology and coding dictionaries (MedDRA, WHODrug).
- Skilled at translating complex technical data issues into clear, actionable summaries for non-DM stakeholders, including program leadership and cross-functional teams.
- Excellent interpersonal and communication skills (verbal and written); ability to work independently and collaboratively, managing multiple projects simultaneously in a fast-paced, innovative environment.
- Ability to contribute to and improve the quality of internal data management policies, programs, and initiatives.
- Alignment with core values: Rewrite the Future; On the Cutting Edge; Better Together; Dynamically Different; Kindness and Integrity.
