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 include leading and managing data management teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional teams and vendors, and ensuring data management processes meet regulatory standards. This role requires extensive experience in clinical data management, strong leadership and communication skills, expertise in clinical trial methodologies, and a deep understanding of regulatory requirements including submissions and data management systems.

Required Skills, Experience and Education:

• 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.

• 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).

• 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.

• 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.

• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.

• 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.

• 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.

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). #LI-Hybrid  #LI-DN1