Associate Director, Clinical Data Management
Artiva Biotherapeutics
August 18, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Associate Director, Clinical Data Management
Duties/Responsibilities:
- Execute CDM strategy, including technology platforms, data standards, vendor governance, and quality frameworks aligned with 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 deliver integrated, inspection-ready data.
- Drive departmental SOPs, working practices, and process improvement; ensure CDM readiness for internal audits and regulatory inspections.
- Provide senior oversight of CDM activities across assigned programs from study start-up through database lock, ensuring timely delivery of high-quality data.
- Lead or oversee development/review of DM documents including CRFs, Data Management Plans, edit check specifications, Data Review Plans, and SAE reconciliation plans.
- Lead UAT strategy and execution for EDC builds; maintain UAT standards.
- Manage and govern CRO/third-party vendor relationships for DM activities; oversee scope, quality, timelines, and budget; proactively escalate and resolve issues.
- Drive program-level DM timelines; maintain cross-study visibility of milestones, risks, and resources; report status to leadership.
- Coordinate and lead data quality reviews; participate in study/project meetings; foster a culture of quality and continuous improvement.
- Champion CDISC standards (CDASH, SDTM) and EDC best practices; evaluate/implement tools/technologies to improve quality and efficiency; mentor and develop CDM staff.
Requirements:
- 10+ years clinical data management experience (pharma/biotech/CRO), including 5+ years in progressive leadership roles.
- Experience managing CDM activities directly and through CRO/third-party providers.
- Deep expertise in EDC (Medidata Rave preferred) and clinical data standards (CDISC CDASH/SDTM, ICH GCP E6(R3), 21 CFR Part 11).
- Proven CRO/third-party DM vendor management across multiple concurrent studies.
- Strong cross-functional communication and stakeholder management; ability to influence without authority.
- Preferred: experience supporting regulatory submissions (IND, NDA/BLA) and/or inspection readiness.
- Bachelor’s degree in life sciences, computer science, or related field; advanced degree a plus.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.
Base Salary: $190,000–$205,000 (exact compensation may vary).
Duties/Responsibilities:
- Execute CDM strategy, including technology platforms, data standards, vendor governance, and quality frameworks aligned with 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 deliver integrated, inspection-ready data.
- Drive departmental SOPs, working practices, and process improvement; ensure CDM readiness for internal audits and regulatory inspections.
- Provide senior oversight of CDM activities across assigned programs from study start-up through database lock, ensuring timely delivery of high-quality data.
- Lead or oversee development/review of DM documents including CRFs, Data Management Plans, edit check specifications, Data Review Plans, and SAE reconciliation plans.
- Lead UAT strategy and execution for EDC builds; maintain UAT standards.
- Manage and govern CRO/third-party vendor relationships for DM activities; oversee scope, quality, timelines, and budget; proactively escalate and resolve issues.
- Drive program-level DM timelines; maintain cross-study visibility of milestones, risks, and resources; report status to leadership.
- Coordinate and lead data quality reviews; participate in study/project meetings; foster a culture of quality and continuous improvement.
- Champion CDISC standards (CDASH, SDTM) and EDC best practices; evaluate/implement tools/technologies to improve quality and efficiency; mentor and develop CDM staff.
Requirements:
- 10+ years clinical data management experience (pharma/biotech/CRO), including 5+ years in progressive leadership roles.
- Experience managing CDM activities directly and through CRO/third-party providers.
- Deep expertise in EDC (Medidata Rave preferred) and clinical data standards (CDISC CDASH/SDTM, ICH GCP E6(R3), 21 CFR Part 11).
- Proven CRO/third-party DM vendor management across multiple concurrent studies.
- Strong cross-functional communication and stakeholder management; ability to influence without authority.
- Preferred: experience supporting regulatory submissions (IND, NDA/BLA) and/or inspection readiness.
- Bachelor’s degree in life sciences, computer science, or related field; advanced degree a plus.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long Term Disability; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.
Base Salary: $190,000–$205,000 (exact compensation may vary).