AD Clinical Data Manager

Overview

• Lead and oversee clinical data management activities for complex trials, ensuring compliance with regulatory standards and high-quality deliverables.
• Collaborate with cross-functional teams to develop and implement data management strategies and project execution plans.
• Provide expertise in electronic data capture systems and clinical trial data processes to optimize operational efficiency.
• Develop and maintain detailed data management timelines, ensuring adherence to project schedules and milestones.
• Support organizational growth through process improvement initiatives and innovative solutions.
• Mentor and train junior data managers, fostering professional development and team collaboration.
• Manage vendor relationships and oversee outsourced data management services to ensure quality and efficiency.
• Ensure data integrity and quality throughout the clinical trial lifecycle, maintaining compliance with industry standards.

Key Responsibilities & Duties

• Act as the primary contact for study teams, ensuring data deliverables meet quality and regulatory standards.
• Lead planning and execution of comprehensive data management activities for assigned clinical studies.
• Develop, maintain, and archive essential data management documents for clinical trials.
• Establish and lead Data Working Groups to coordinate and streamline data management efforts.
• Implement risk mitigation strategies to address data handling challenges and ensure project success.
• Coordinate data transfers and reconciliation processes with external vendors, ensuring accuracy and compliance.
• Ensure adherence to Good Clinical Practice (GCP) and FDA regulations in all data management activities.
• Contribute to electronic submission activities and preparation of regulatory documentation.

Job Requirements

• Bachelor’s degree in a related discipline; advanced degrees preferred for enhanced expertise.
• Minimum of 10 years of industry experience, including 4 years in project leadership roles.
• Proficiency in Electronic Data Capture (EDC) systems and clinical trial data management processes.
• In-depth knowledge of GCP and FDA regulations governing clinical trials and data management practices.
• Experience with CDASH/CDISC standards and data management tools is preferred.
• Strong analytical, communication, and leadership skills to drive team success.
• Ability to manage multiple projects simultaneously and meet tight deadlines effectively.
• Demonstrated expertise in vendor management and cross-functional collaboration.