Senior Clinical Data Manager

Overview

• Lead and manage clinical trial databases through the full data management lifecycle.
• Serve as the primary liaison between internal and sponsor personnel, ensuring effective communication.
• Develop and oversee database design specifications, validation, and maintenance activities.
• Provide guidance and delegate tasks to team members across multiple projects.
• Ensure adherence to study timelines and deliverables while maintaining data quality standards.
• Participate in client study kickoff and closeout meetings, presenting findings and lessons learned.
• Utilize centralized data management platforms for strategic data cleaning and reporting.
• Mentor junior staff and peers, fostering professional growth and development.

Key Responsibilities & Duties

• Monitor and ensure adherence to study timelines and deliverables.
• Develop and oversee data management documents, including DMPs and CRFs.
• Perform data review for consistency, accuracy, and vendor data reconciliation.
• Provide ongoing data management reports and metrics to stakeholders.
• Define and develop specifications for database and programming changes.
• Track data management issues and ensure timely resolution.
• Assist in process improvement initiatives and SOP creation.
• Participate in proposal defenses and other management-requested duties.

Job Requirements

• Bachelor’s degree in Pharmaceutical/Biotechnology or related health field preferred.
• 8+ years of Clinical Data Management experience with CRO exposure.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.
• Proficiency in EDC systems and Clinical Data Management Systems.
• Strong project management and team leadership skills.
• Excellent verbal and written communication abilities.
• Proficiency in Microsoft Office Applications, including MS Project and Excel.
• Experience in centralized data management platforms for analytics and reporting.