Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

Redwood City, CA (Hybrid)

Our client is a clinical-stage biotechnology company advancing a pipeline of innovative therapies across multiple therapeutic areas. As the organization continues to grow, they are seeking an experienced Associate Director, Clinical Data Management to lead data management strategy and execution across multiple clinical development programs.

This individual will play a key leadership role in ensuring the quality, integrity, and accessibility of clinical trial data while partnering closely with Clinical Operations, Biometrics, Pharmacovigilance, Regulatory Affairs, and external vendors. The ideal candidate will bring strong technical expertise, vendor management experience, and a passion for building scalable, high-quality clinical data management processes within a collaborative biotech environment.

Key Responsibilities

Clinical Data Management Leadership

• Lead and oversee clinical data management activities across multiple clinical development programs.
• Develop and optimize data flow strategies across EDC and non-EDC data sources.
• Ensure clinical databases are accurate, complete, inspection-ready, and compliant with industry standards.
• Support implementation and maintenance of CDISC-compliant data standards and data governance practices.
• Review study protocols and CRFs to ensure data collection aligns with study objectives and operational requirements.

Vendor & CRO Management

• Manage Data Management CROs and external vendors responsible for database build, data cleaning, reconciliation, and study deliverables.
• Oversee vendor performance, timelines, quality metrics, and operational deliverables.
• Evaluate and implement technologies that enhance real-time data visualization, reporting, and access.
• Drive continuous improvement initiatives across vendor processes and workflows.

Data Quality & Oversight

• Monitor clinical data quality through ongoing review of data review metrics, query trends, and reconciliation activities.
• Oversee SAE reconciliation between clinical and pharmacovigilance systems.
• Ensure timely delivery of clean, reliable clinical data to internal stakeholders.
• Contribute to database development, validation, maintenance, and lifecycle management.
• Support inspection readiness and participate in internal and external audits.

Process Improvement

• Develop and improve SOPs, work instructions, templates, and best practices for Clinical Data Management.
• Identify opportunities to improve operational efficiency, automation, and data accessibility.
• Provide subject matter expertise across cross-functional project teams throughout the clinical development lifecycle.

Qualifications

Required

• Bachelor's degree in Life Sciences, Computer Science, Mathematics, or a related scientific discipline.
• 10+ years of Clinical Data Management experience within biotechnology, pharmaceutical, medical device, or CRO environments.
• Demonstrated experience managing clinical data across multiple clinical studies.
• Strong experience overseeing Data Management CROs and external vendors.
• Working knowledge of ICH-GCP, GCDMP, 21 CFR Part 11, and applicable regulatory requirements.
• Experience with CDISC standards and clinical database management.
• Strong leadership, communication, and project management skills.

Preferred

• Master's degree in a scientific or healthcare-related discipline.
• Hands-on experience with leading EDC platforms such as Medidata Rave, Medrio, Inform, or similar systems.
• Experience with SQL, SAS, relational databases, and data visualization tools such as Tableau, Spotfire, or R Shiny.
• Familiarity with MedDRA, WHODrug, and controlled terminology standards.
• Experience supporting biomarker data integration and external data sources.
• Experience working in small or emerging biotechnology companies.
• Previous people management experience.
• Experience supporting endocrine, metabolic, or other complex therapeutic area clinical programs is a plus.