Senior Director, Clinical Data Management (Clinical Data Systems and Ops Ex)

17 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.

Help define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs, with a focus on data standards, systems, system integration and operational excellence and efficiency.

Extensive experience in clinical data management processes and systems, with proven leadership experience in oncology therapeutic area.

Proven track record of developing and implementing clinical data standards and governance, with a focus on Oncology data standards.

Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms, RSG implementation/E2B, in-house coding implementation, in-house CTMS development support, other clinical development systems implementation and integrations).

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

The Senior Director of Clinical Data Management (CDS OpsEx) provides high-level leadership for Data Management and functions within clinical development including Information Operations, Data Products, and Clinical Data systems, focusing on strategic development, operational execution and excellence, and regulatory compliance to ensure data integrity for clinical trials.

Key responsibilities include leading and managing data management and cross-functional teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional stakeholders and vendors, and ensuring data management processes, systems and systems integrations meet regulatory standards.

This role requires extensive experience in the clinical data management setting, strong leadership and communication skills, expertise in clinical trial methodologies and systems, and a deep understanding of regulatory requirements including submissions and data management systems.