We are seeking an experienced Clinical Data Manager to support clinical studies and ensure the accuracy, integrity, and quality of clinical data throughout the study lifecycle. The ideal candidate will have strong analytical and critical-thinking skills, hands-on clinical data management experience, and the ability to collaborate effectively with cross-functional teams in a regulated environment.
This role will be responsible for supporting clinical data risk assessment, CRF development, database development, edit checks, data review, discrepancy management, data cleaning, and database freeze/lock activities.
Key Responsibilities
Lead and collaborate with cross-functional clinical project teams during protocol development to identify critical data required for reliable study results and patient safety.
Conduct clinical data risk assessments by reviewing protocols and study plans, identifying data-related risks, and developing appropriate mitigation strategies.
Lead the development and revision of Case Report Forms (CRFs), edit checks, data listings, and clinical database requirements.
Partner with Study Database Managers and cross-functional teams during clinical database development, testing, validation, and release.
Identify, program, review, and test database edit checks to ensure data accuracy and completeness.
Perform ongoing review and analysis of subject-level clinical data to identify discrepancies, trends, outliers, and potential data-quality issues.
Generate and manage data queries with clinical sites and ensure timely resolution of discrepancies.
Identify systemic or significant data-quality issues and coordinate escalation and resolution with Project Management, Site Management, Clinical Science, Biometrics, Safety, and other stakeholders.
Manage study-wide discrepancy issuance and resolution throughout the clinical study lifecycle.
Conduct root-cause analysis of recurring discrepancy trends and support development of system-level corrective actions and process improvements.
Develop and implement focused data-cleaning and quality-control activities based on identified study risks.
Support targeted site instructions and study-specific Central Monitoring and Site Monitoring plans related to data quality.
Monitor progress toward data-cleaning, data-freeze, and database-lock milestones.
Ensure clinical data is complete, accurate, and ready for regulatory submission and other study milestones.
Partner with Clinical Data Coordinators to monitor discrepancy trends and drive timely resolution.
Present data-quality findings, risks, trends, and recommendations to cross-functional stakeholders and leadership.
Lead discussions and influence cross-functional teams to drive effective clinical data management decisions.
Maintain and contribute to clinical data review standards, procedures, and best practices.
Ensure compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and internal procedures.
Identify opportunities for continuous improvement and support enhancements to clinical data management processes and systems.
Required Qualifications
Bachelor’s degree in Biology, Health Sciences, Mathematics, Computer Science, Life Sciences, or a related technical field; equivalent education and experience may be considered.
5+ years of experience in clinical operations, clinical data management, healthcare, life sciences, or a related field.
Hands-on experience with clinical data management activities within regulated clinical studies.
Strong knowledge of Good Clinical Practice (GCP) and global regulations applicable to investigational studies.
Experience with CRF development, clinical databases, edit checks, data cleaning, data queries, and database freeze/lock activities.
Strong analytical, problem-solving, and critical-thinking skills.
Excellent written and verbal communication skills.
Demonstrated ability to collaborate with and influence cross-functional teams.
Ability to lead discussions and manage complex clinical studies in a regulated environment.
Preferred Qualifications
Experience in the medical device, pharmaceutical, biotechnology, or healthcare industry.
Experience with EDC systems and clinical database management.
Experience supporting regulatory submissions and database lock activities.
Experience with clinical data risk management and centralized data review.
Certified Clinical Data Manager (CCDM) certification is preferred.
Experience with therapy-specific data review standards and best practices.

Clinical Data Manager

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