AD Clinical Data Manager

Overview

• Lead clinical data management operations for complex trials, ensuring high-quality deliverables and regulatory adherence.
• Collaborate with cross-functional teams to develop innovative strategies for data capture and management.
• Provide expertise in electronic data systems to optimize trial data processes and integrity.
• Develop and maintain detailed project timelines to ensure milestone adherence and efficient execution.
• Drive organizational growth through process improvements and innovative solutions in data management.
• Mentor and train junior team members, fostering professional development and collaboration.
• Manage vendor relationships to ensure quality and efficiency of outsourced services.
• Ensure data integrity and quality throughout the clinical trial lifecycle.

Key Responsibilities & Duties

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

Job Requirements

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