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Associate Director, Clinical Data Management

$190k - $205k

Artiva Biotherapeutics

Associate Director, Clinical Data Management

Artiva Biotherapeutics is seeking a Associate Director, Clinical Data Management to lead and scale our CDM function as we advance our NK cell therapy pipeline. This is a senior leadership role that combines hands-on program oversight with organizational accountability and serve as the internal subject matter expert on all things data management. This role is responsible for managing end-to-end data management activities across one or more clinical studies.

Reporting to the Director or Head of Clinical Development Operations, the AD will be a key partner to Clinical Operations, Biostatistics, Translational Sciences, and Regulatory Affairs driving quality, timelines, and innovation across Artiva's clinical data infrastructure. This is an ideal opportunity for a seasoned CDM leader who is energized by the opportunity to shape a function from the ground up in a high-impact, mission-driven organization.

Duties/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.

Requirements:

  • 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 (Medidata Rave preferred) 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
  • Experience supporting regulatory submissions (IND, NDA/BLA) and/or inspection readiness activities preferred
  • Bachelor's degree in life sciences, computer science, or related field; advanced degree a plus

In addition to a great culture, we offer:

  • A beautiful facility
  • An entrepreneurial, highly collaborative, and innovative environment
  • Comprehensive benefits, including:
    • 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.

If all this speaks to you, come join us on our journey!

Base Salary: $ 190,000 - $205,000. Exact compensation may vary based on level, skills and experience.

Artiva Biotherapeutics
Vacancy posted 1 day ago
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