Associate Director, Clinical Data Management

This is a fully remote position, open to applicants in California.

📋 Description

• Implement Artiva's Clinical Data Management (CDM) strategy, encompassing technology platforms, data standards, vendor governance, and quality frameworks, in accordance with overarching Clinical Development goals.

• Act as the CDM functional representative within program teams and governance forums; collaborate with Clinical Operations, Biostatistics, Regulatory, and Translational Sciences to guarantee integrated, inspection-ready data delivery.

• Lead the establishment of departmental standard operating procedures (SOPs), working practices, and initiatives for process improvement; ensure the CDM function is ready for internal audits and regulatory inspections.

• Provide senior oversight of all CDM activities across designated programs from study initiation to database lock, ensuring the timely provision of high-quality, accurate, and complete data.

• Direct or supervise the development and evaluation of data management documents, including Case Report Forms (CRFs), Data Management Plans, edit check specifications, Data Review Plans, and Serious Adverse Event (SAE) reconciliation plans.

• Oversee Artiva's User Acceptance Testing (UAT) strategy and implementation for Electronic Data Capture (EDC) builds; ensure UAT standards are upheld throughout the program.

• Manage and govern relationships with Contract Research Organizations (CROs) and third-party vendors for data management activities; supervise scope, quality, timelines, and budget; proactively escalate and resolve issues.

• Drive program-level data management timelines; maintain visibility across studies regarding milestones, risks, and resource requirements; report status updates to leadership.

• Organize and lead Artiva's data quality reviews.

• Participate in regular study and project team meetings.

• Promote a culture of quality and continuous improvement.

• Advocate for the adoption of CDISC standards (CDASH, SDTM) and best practices for EDC across the organization.

• Assess and implement tools and technologies that enhance data quality, efficiency, and real-time data visibility (e.g., integration of risk-based monitoring, automation of data review).

• Mentor and nurture CDM staff at all levels.

⛳️ Requirements

• Over 10 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO sectors, with at least 5 years in progressive leadership positions.

• Proven experience in managing and overseeing data management activities both directly and through CROs or third-party service providers.

• Extensive knowledge of EDC systems (preferably Medidata Rave) and clinical data standards (CDISC CDASH/SDTM, ICH GCP E6(R3), 21 CFR Part 11).

• A successful track record in managing CRO and third-party data management vendor relationships across multiple concurrent studies.

• Strong skills in cross-functional communication and stakeholder management; ability to influence without authority at all organizational levels.

• Experience in supporting regulatory submissions (IND, NDA/BLA) and/or readiness for inspections is preferred.

• Bachelor's degree in life sciences, computer science, or a related field; an advanced degree is a plus.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• 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 a week off during the year-end holiday season.

• Recognition program, Bonus.ly.