СШАAssociate Director, Data Manager
2 нед. назад
185k–220k USD / годСШАDirectorHybrid
Associate Director responsible for data management at a biopharmaceutical company focusing on genetic medicines.
О компании
- 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 las
Обязанности
- 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 Development, Biostatisticians, Statistical Programmers, Pharmacovigilance, Regulatory, Translational Research, and Clinical Operations.
- Provide input into study protocols, SAPs, and other clinical documents to ensure quality data collection and management; map data flows, processes, and systems used for collection, management, and provision of data to downstream functional area users.
- Accountable for all data management deliverables including Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, and Lab Specifications, ensuring adherence to study plans and SOPs.
- Oversee EDC and clinical data system builds, including vendor UATs for database builds and migrations, managing impacts from mid-study updates.
- Establish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure electronic data transfers from external vendors (e.g., IXRS, specialty labs) are executed to plan.
- Oversee CRO data cleaning activities including processing queries, performing ongoing data review, and identifying and tracking data issues and trends to give transparency to Global Development Program Leads and other program team members.
- Coordinate with CRO on data metrics, trending, and reports for data review meetings with internal stakeholders; assist in defining data listings and data specifications in preparation for statistical review and data management audits.
- Ensure data system compliance by following the established guidelines of national and international regulatory authorities.
- Support close-out audit for closing of study trials in EDC or other clinical data management databases; contribute to departmental process and standards development.
- Accountable to deliver the study against the study budget.
- Possesses an in-depth understanding of regulatory guidance, e.g., ICH, GCDMP, 21 CFR Part 11.
Требования
- 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.
- 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.
- Proficient 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; ability to clearly communicate, resolve complex issues, and mitigate risks.
- 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.
- Embrace our core values: Rewrite the Future; On the Cutting Edge; Better Together; Dynamically Different; Kindness and Integrity
Другое
- 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.