Note: The job is a remote job and is open to candidates in USA. Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing NK cell-based therapies. They are seeking an Associate Director, Clinical Data Management to lead and scale their CDM function, manage end-to-end data management activities, and collaborate with various departments to ensure quality and timely delivery of clinical data.
Responsibilities
- Execute Artiva's CDM strategy — including technology platforms, data standards, vendor governance, and quality frameworks — in alignment with overall Clinical Development objectives
- Serve as the CDM functional representative on program teams and governance forums; partner with Clinical Operations, Biostatistics, Regulatory, and Translational Sciences to ensure integrated, inspection-ready data delivery
- Drive departmental SOPs, working practices, and process improvement initiatives; ensure the CDM function is prepared for internal audits and regulatory inspections
- Provide senior oversight of all CDM activities across assigned programs from study start-up through database lock, ensuring timely delivery of high-quality, clean, and complete data
- Lead or oversee development and review of DM documents including CRFs, Data Management Plans, edit check specifications, Data Review Plans, and SAE reconciliation plans
- Lead Artiva UAT strategy and execution for EDC builds; ensure UAT standards are maintained across the program
- Manage and govern CRO and third-party vendor relationships for DM activities; oversee scope, quality, timelines, and budget; escalate and resolve issues proactively
- Drive program-level DM timelines; maintain cross-study visibility of milestones, risks, and resource needs; report status to leadership
- Coordinate and lead Artiva data quality reviews
- Participate in regular study and project team meetings
- Foster a culture of quality and continuous improvement
- Champion CDISC standards adoption (CDASH, SDTM) and EDC best practices across the organization
- Evaluate and implement tools and technologies that advance data quality, efficiency, and real-time data visibility (e.g., risk-based monitoring integration, data review automation)
- Mentor and develop CDM staff at all levels
Skills
- 10+ years of clinical data management experience in pharma, biotech, or CRO, with 5+ years in progressive leadership roles
- Demonstrated experience managing and overseeing Data Management activities directly and through CRO/third-party service providers
- Deep expertise in EDC systems and clinical data standards (CDISC CDASH/SDTM, ICH GCP E6(R3), 21 CFR Part 11)
- Proven track record managing CRO and third-party DM vendor relationships across multiple concurrent studies
- Strong cross-functional communication and stakeholder management skills; ability to influence without authority at all levels of an organization
- Bachelor's degree in life sciences, computer science, or related field
- Experience supporting regulatory submissions (IND, NDA/BLA) and/or inspection readiness activities preferred
- Medidata Rave preferred
- Advanced degree a plus
Benefits
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Company Overview
Company H1B Sponsorship