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Artiva Biotherapeutics, a clinical-stage biotech company developing NK cell-based therapies for autoimmune diseases, is seeking an Associate Director of Clinical Data Management to lead and scale the CDM function as the company advances its pipeline. Reporting to the Director or Head of Clinical Development Operations, this senior leadership role combines hands-on program oversight with organizational accountability, positioning the successful candidate as the internal subject matter expert on data management across all clinical studies.
Key responsibilities include executing Artiva's CDM strategy—including technology platforms, data standards, vendor governance, and quality frameworks—in alignment with clinical development objectives. The role requires serving as the CDM functional representative on program teams and governance forums, partnering closely with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Sciences to ensure integrated, inspection-ready data delivery. The Associate Director will drive departmental SOPs, working practices, and process improvement initiatives while ensuring the CDM function is prepared for internal audits and regulatory inspections.
Program execution responsibilities span the full lifecycle from study start-up through database lock, including oversight of all CDM activities, development and review of data management documents (CRFs, Data Management Plans, edit check specifications, Data Review Plans, SAE reconciliation plans), and leadership of UAT strategy and execution for EDC builds. The role involves managing and governing CRO and third-party vendor relationships, driving program-level DM timelines, maintaining cross-study visibility of milestones and risks, and coordinating data quality reviews.
The ideal candidate will champion CDISC standards adoption (CDASH, SDTM) and EDC best practices, evaluate and implement tools that advance data quality and efficiency, and mentor CDM staff at all levels. This is an opportunity to shape a critical function from the ground up in a mission-driven, high-impact organization.
