Clinical Data Manager

About the Role

The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems as outlined in the risk assessment, data management plan, and site/central monitoring plans. Serving as the primary liaison and functional lead for Data Review, the Clinical Data Manager applies therapy-specific knowledge to ensure alignment with customer definitions of criticality and informs the review and analysis of clinical study data.

Responsibilities

• Identify study-specific risks to study conduct and human subject safety; analyze risks and develop, implement, and track mitigation strategies.
• Review study data to detect anticipated and unanticipated issues related to trial data completeness, accuracy, and overall quality.
• Facilitate multi-stakeholder discussions to review data findings, evaluate operational impact, and develop action plans for correction and continuous monitoring.
• Execute Central Monitoring activities in alignment with the approved Central Monitoring Plan.
• Direct and oversee all data cleaning activities for assigned clinical studies.

Requirements

• Bachelor’s Degree (or equivalent) in Biology, Health Sciences, Mathematics, Computer Science, or a related field.
• Minimum 3 years of experience in clinical operations or a healthcare-related field.
• Background in project management, life sciences, and/or technical disciplines within clinical research.
• Strong knowledge of global clinical operations and data collection best practices for clinical trials.
• Proficiency in translating clinical trial requirements into technical specifications required for effective data collection.
• Intermediate therapy-specific knowledge in anatomy, physiology, pathophysiology, therapies, and medical devices.

Skills

• Consultative & Influence Skills: Proven experience serving as a Subject Matter Expert (SME) and effectively influencing cross-functional team decisions to achieve project goals.
• Risk Identification & Mitigation: Skilled in identifying process risks, evaluating likelihood and impact, and developing practical, effective mitigation and monitoring strategies.
• Analytical Thinking: Adept at making inferences and connections based on limited information, with the ability to clearly articulate knowns, unknowns, and alternative explanations.
• Project Management: Intermediate project management skills, including creating multifaceted plans with complex dependencies and holding peers accountable while fostering positive, collaborative relationships.
• Fluent in English (written and verbal).

Certified Clinical Data Manager (CCDM) or equivalent preferred (not required).