Associate Director, Clinical Data Management

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

📋 Description

• Oversee clinical data management functions for assigned studies and/or programs, ensuring that clinical trial data deliverables are accurate, complete, timely, high-quality, and ready for inspection.

• Provide operational guidance throughout the clinical data lifecycle, which includes strategies for data collection, EDC/database construction, external data integration, data review, reconciliation, database lock readiness, and the delivery of clinical data.

• Lead the creation and implementation of CDM deliverables such as data management plans, data review plans, database specifications, edit check specifications, query management procedures, quality assessments, database audits, and database lock strategies.

• Spearhead or assist in technology advancement and modernization initiatives, focusing on scalable EDC constructions, standard libraries, reusable CRFs/edit checks, automation, AI-driven data review processes, and biometrics standardization.

• Collaborate with Biostatistics and Statistical Programming to ensure traceability from protocol and CRF design to SDTM-ready and analysis-ready data.

• Track CDM metrics, dashboards, and operational reports to assess data quality, query patterns, vendor performance, cycle times, reconciliation status, lock readiness, and the achievement of milestones.

• Identify, escalate, and resolve intricate CDM issues, such as data quality trends, database discrepancies, challenges with external data reconciliation, vendor performance issues, and risks associated with cross-functional processes.

• Direct CROs, vendors, contractors, and external partners; oversee performance, deliverables, quality, timelines, issue resolution, and compliance.

• Represent CDM in study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress updates.

• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors.

• Suggest enhancements to CDM processes, standards, templates, work practices, and governance frameworks.

• Ensure adherence to regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specific requirements.

• Assist with CDM-related inspections, audits, quality assessments, data integrity initiatives, and corrective/preventive actions.

• Offer coaching, performance feedback, and development support to CDM employees, contractors, and team members across various matrices.

• Contribute to resource planning, vendor proposal evaluations, staffing needs assessments, timeline planning, and capability development.

• Provide input into protocol design, CRF design, data standards, endpoint implementation, and consistency across studies.

• Stay updated on industry trends, technologies, data standards, and evolving regulatory expectations; recommend improvements to processes or systems.

• Perform additional duties as assigned.

⛳️ Requirements

• BS/BA Degree in Computer Science or a related Life Science field with over 10 years of experience in Clinical Data Management within a biopharmaceutical context, or a Master's Degree in Computer Science or a related Life Science field with at least 8 years of relevant experience, or a PhD with a minimum of 6 years of similar experience.

• Significant experience leading Clinical Data Management activities across multiple clinical studies and/or programs in biotechnology, pharmaceutical, or CRO settings.

• Comprehensive understanding of the clinical data lifecycle, including data collection strategies, CRF design, EDC/database construction, external data integration, data review, reconciliation, database locking, and clinical data delivery.

• Familiarity with EDC platforms and associated CDM systems; experience with Medidata Rave is preferred.

• Experience with clinical data standards such as CDASH, SDTM, controlled terminology, standard CRF libraries, and cross-study standardization.

• Proven ability to collaborate with Biostatistics and Statistical Programming to ensure effective data collection, end-to-end traceability, and analysis-ready data.

• Experience managing CROs, vendors, contractors, and external data providers in outsourced or hybrid operational models.

• Knowledge of GCP, ICH guidelines, regulatory requirements, data integrity principles, SOPs, and inspection-readiness criteria.

• Experience utilizing CDM metrics and dashboards to monitor quality, predictability, vendor performance, and database locking readiness.

• Background in contributing to process enhancements, technology enablement, and modernization efforts, including scalable EDC build methods, standard libraries, automation, AI-driven data review processes, and/or data visualization tools.

• Experience in people leadership, including coaching, development, and management of CDM employees, contractors, or matrixed team members.

• Strong skills in communication, collaboration, problem-solving, decision-making, and stakeholder management within a fast-paced, matrixed environment.

🏝️ Benefits

• Annual bonus with a target of 30% of earned base salary.

• Eligibility to participate in an equity-based long-term incentive program.

• Retirement savings plan with company matching contributions.

• Paid vacation, holidays, and personal days.

• Paid caregiver/parental leave and medical leave.

• Comprehensive medical, prescription drug, dental, and vision coverage.