Role Summary
The Associate Clinical Data Manager supports the planning and execution of clinical study data management activities. Under the direction of a manager, this role leads cross-functional teams through case report form development, database setup, data review, and data cleaning processes to ensure the integrity and quality of clinical study data throughout the lifecycle of an investigation.
Key Responsibilities
• Leads cross-functional teams during protocol development to identify and document data critical to the reliability of study results and protection of human subjects.
• Manages the development and revision of case report forms (CRF), edit checks, data listings, and clinical database setup.
• Identifies and evaluates residual risks to critical study data; oversees development of additional mitigations including focused data cleaning, quality activities, and targeted site instructions.
• Leads the Clinical Project Team through CRF development and partners with the Study Database Manager through database development, release, programming, and testing of edit checks.
• Conducts review and analysis of subject data as it accumulates, resolving discrepant or aberrant data points via queries to study sites.
• Identifies systemic or significant data quality issues requiring escalation; manages escalation in partnership with Project Management, Site Management, Clinical Science, Biometrics, and Safety.
• Manages progress toward data cleaning and data freeze/lock targets for regulatory submission.
• Manages issuance and resolution of discrepancies over the study lifecycle, including root cause analysis and development of system-level countermeasures and process improvements.
• Leads proactive partnership with field and study team personnel, presenting findings from central monitoring and data review activities.
• Assists in ongoing risk evaluation through in-depth review of protocol and plan documentation, validation of risk findings, and development of process-based controls.
• Contributes to the maintenance of data review standards and best practices.
Required Qualifications
• Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, or equivalent field.
• Minimum 5 years of experience in clinical operations or a healthcare-related field.
• Knowledge of Good Clinical Practice (Google Cloud Platform) and global regulations for investigational studies.
• Strong analytical and critical thinking skills with demonstrated data management experience.
• Strong written and verbal communication skills; ability to lead discussions and manage complex regulated studies.
• Ability to effectively influence cross-functional team decisions.
Preferred Qualifications
• Certified Clinical Data Manager (CCDM) designation.
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