Senior Director, Clinical Data Management

The Opportunity

The Senior Director of Clinical Data Management provides high-level leadership for data management functions within clinical research, focusing on strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials.

Key Responsibilities

• Define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs
• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews
• Develop and monitor KPIs for data quality and operational performance
• Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards
• Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures
• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies
• Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits
• Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders
• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency

Required Qualifications

• MS, BS/BA degree, or other suitable qualification with relevance to the field
• 17 or more years' direct experience in clinical data management in the biotechnology or pharmaceutical industry
• Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area
• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes
• Experience with global trials and regulatory submissions (FDA, EMA)
• In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding)
• Demonstrated ability to lead, motivate, and develop teams
• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders
• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions

Preferred Skills

• A degree in life science, health informatics, or a related field
• Exposure to real-world data (RWD) and decentralized trial models
• Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms)

Pay

Base pay salary range for this full-time position for candidates working onsite at the headquarters in Redwood City, CA is $244,000 - $305,000 USD. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.