Executive Director, Clinical Data Systems

Overview

• Lead the strategic direction for clinical data systems, ensuring alignment with organizational goals and industry standards.
• Develop and implement innovative policies for efficient clinical data acquisition and management.
• Collaborate with cross-functional teams to enhance data quality and operational excellence.
• Drive advancements in data collection methodologies and technologies.
• Provide executive-level leadership in vendor management and compliance oversight.
• Represent the department in strategic discussions and organizational planning.
• Ensure adherence to global regulatory standards and clinical practices.
• Manage budgets and resources effectively to support departmental objectives.

Key Responsibilities & Duties

• Define and execute strategies for optimized clinical data acquisition and management.
• Oversee comprehensive data management activities across all clinical study phases.
• Lead and mentor a team of professionals to achieve departmental goals.
• Establish governance frameworks for vendor oversight and quality assurance.
• Implement continuous improvement initiatives to enhance operational efficiency.
• Support regulatory submissions and inspections with robust data processes.
• Collaborate with senior leadership to align strategies with organizational objectives.
• Ensure effective record retention and documentation practices.

Job Requirements

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum of 18 years of experience in clinical data management within the Biotech/Pharmaceutical industry.
• Proven expertise in leading global data management teams and initiatives.
• Extensive experience with regulatory submissions and compliance processes.
• Strong knowledge of CDISC standards, GCP, and clinical development protocols.
• Exceptional leadership skills with the ability to inspire and guide teams.
• Demonstrated ability to manage change and drive innovation in complex environments.
• Excellent analytical, organizational, and communication skills.