Associate Director, Clinical Data Management

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🔥 1 hour ago

🏄 California – Remote

🏄 California – Remote

💵 $190k - $205k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• 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

🏖️ 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 • Recognition program, Bonus.ly