Associate Director, Data Manager

Company

Summary:

Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability.

Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts.

We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work.

Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.

Reporting to the Director, Clinical Data Management, the Associate Director, Clinical Data Management leads clinical data management activities across one or more global studies/programs, ensuring timely delivery of high-quality, audit-ready clinical trial data in support of regulatory submissions and clinical development timelines. Acts as the primary data management point of contact for assigned studies/programs, overseeing CRO and vendor performance, database design, and data cleaning strategy from study start-up through database lock.

Partners closely with cross-functional team members to ensure data management deliverables align with study milestones, data quality objectives, and inspection-readiness standards. May contribute to departmental process and standards development.

Must have excellent written and oral communication skills and interpersonal skills, with the ability to build relationships, analyze complex issues, and resolve and mitigate risks. Must thrive in a small, fast-paced, innovative environment. Flexibility to attend meetings in different global time zones.

Accountable for delivering all data management tasks for assigned global studies/programs from study start-up through database closure and archival, producing high-quality databases for analysis and potential regulatory submissions, on time and within study budget.

• Demonstrate deep expertise in a regulated environment, including presenting data and documentation in support of regulatory requirements for complete and accurate data.
• Contribute to the Data Management function at Korro, authoring, reviewing, and maintaining policies and methods in standard operating procedures, work instructions, job aids, and other training documents.
• Serve as the clinical data management subject matter expert, providing representation and guidance to internal and external teams for assigned global studies/programs, including expertise in electronic data capture, external data standardization, collection and processing, and the creation of standard data collection forms, validation checks, and collection processes.
• Work closely with cross-functional members of the study team, including Clinical…