Clinical Data Manager

Clinical Data Manager Overview

• The Clinical Data Manager will oversee clinical data processes, ensuring accuracy and compliance throughout the data lifecycle.
• Collaborate with cross-functional teams to integrate data management activities and enhance operational efficiency.
• Design, implement, and manage data deliverables from study start-up to close-out.
• Stay updated on emerging technologies and industry trends to improve data management practices.
• Ensure compliance with industry standards, regulations, and guidelines for clinical data management.
• Provide leadership and support for data management teams, ensuring quality and timely deliverables.
• Develop and maintain comprehensive study documentation and specifications.
• Perform quality control on deliverables and ensure adherence to best practices.

Clinical Data Manager Key Responsibilities & Duties

• Act as the primary data management representative for client and sponsor interactions.
• Define specifications and collaborate on configuring data cleaning strategies and oversight activities.
• Perform holistic data reviews and trending analyses to identify issues and develop mitigation strategies.
• Monitor and interpret key performance indicators for process improvement.
• Prepare and maintain data management documentation throughout the trial lifecycle.
• Ensure compliance with quality standards, regulations, and clinical trial methodologies.
• Lead data management activities for assigned studies, ensuring successful execution.
• Collaborate with technical teams to enhance data management systems and tools.

Clinical Data Manager Job Requirements

• Bachelor’s degree in a relevant health science or scientific discipline preferred.
• 5+ years of experience in the pharmaceutical or biotechnology industry with clinical data management.
• CCDM Certification is preferred.
• Proficiency in Microsoft Office, EDC systems, and clinical data management tools.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
• Experience with cloud SaaS platforms, data reporting tools, and RBQM methodology preferred.
• Strong project management, analytical, and strategic thinking skills.
• Excellent collaborative and communication skills, both verbal and written.