Edc Director Jobs (NOW HIRING)

About Artiva:

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

For more information, visit www.artivabio.com.

Job Summary:

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:

Leadership & strategy

• 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

Program execution

• 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

Standards & innovation

• 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
• 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.