Clinical Data Manager

About the role

The Clinical Data Manager manages the development, documentation, and execution of risk-based quality management systems as outlined in the risk assessment, data management plan, and site and central monitoring plans. Serving as the customer-facing representative for Data Review and the primary liaison with the therapy group, the Clinical Data Manager leverages therapy-specific knowledge to ensure alignment with customer definitions of criticality and informs the review and analysis of study data.

Responsibilities

• Identify study-specific risks to study conduct and human subject safety; analyze risks and develop and implement mitigation strategies.
• Review study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact, and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities as described in the Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.

Requirements

• Minimum of 3 years of experience in clinical operations or a healthcare-related field.
• Education and work experience in project management, life sciences, and/or a technical field.
• Knowledge of data collection best practices for clinical trials.
• Knowledge of global clinical operations.
• Experience in a consultative role with subject matter expertise and the ability to influence team decisions effectively.
• Proficiency in identifying risks in a process, evaluating likelihood and impact, and developing effective mitigation and monitoring strategies.
• Proficiency in translating clinical trial requirements into technical specifications for effective data collection.
• Ability to make inferences and connections based on limited information, clearly describing knowns, unknowns, and alternative explanations.
• Intermediate project management skills, including developing multifaceted plans with complex dependencies and holding peers accountable while maintaining positive and collaborative relationships.
• Intermediate therapy-specific knowledge of anatomy, physiology, pathophysiology, therapy, and devices.

Qualifications

Certified Clinical Data Manager (CCDM) or equivalent certification is a plus but not required.

Pay

Pay ranges between $35–$42 per hour.