Executive Director, Clinical Data Systems

Overview

• Lead strategic initiatives in clinical data acquisition, ensuring compliance with global standards and regulations.
• Develop and implement advanced policies and procedures for efficient clinical data management.
• Drive innovation in data collection processes using cutting-edge technologies and methodologies.
• Collaborate with cross-functional teams to enhance data quality and operational efficiency.
• Provide leadership in vendor management to ensure controlled and compliant data delivery.
• Represent the Clinical Data Management department in executive-level discussions and decision-making.
• Ensure adherence to industry standards, including CDISC and Good Clinical Practices (GCP).
• Manage departmental budgets and resources effectively to support organizational goals.

Key Responsibilities & Duties

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

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 track record 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.