Clinical Data Manager
About the Position The Clinical Data Manager is responsible for overseeing and executing data management activities across multi-site clinical research studies, with a focus on Electronic Data Capture (EDC) systems, data quality, and regulatory compliance. This role supports the full data lifecycle-from study design and database development through monitoring, analysis readiness, and archival-while ensuring adherence to local, federal, and Department of Defense regulatory requirements. Working cross-functionally with investigators, research staff, statisticians, and regulatory teams, the Clinical Data Manager ensures data integrity, resolves discrepancies, develops standardized documentation, and supports secure and compliant data sharing practices. Compensation: $75,000 - $95,000 QUALIFICATIONS
- Bachelors' degree or equivalent work experience required
- 3-5 years of clinical data management experience desired
- Experience with Electronic Data Capture (EDC) systems, quality control, dataset creation and maintenance
- Experience using REDCap for data collection/management preferred
- Ability to investigate data quality issues and participate in remediation activities
- Statistical and data analysis skills are a must to assist gathering and solving data quality issues
- Experience in data writing requirements
- Intermediate or advanced computer skills including Excel and other Microsoft Software
- Excel Macros experience a plus
- Demonstrated competence in oral and written communication
- Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor
- Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
MANAGEMENT RESPONSIBILITIES
- Oversees quality assurance of all study databases, proactively tests data to identify data integrity issues, makes recommendations, and plans solutions based on research goals
RESPONSIBILITIES
- Advises on, adheres to, and completes data requirements and plans for the full data life cycle from project conception to long term data storage and usage
- Design and modify Case Report Forms (CRFs) in response to IRB modifications and protocol changes
- Author and execute comprehensive User Acceptance Testing (UAT) and validation testing plans to ensure database functionality
- Defines data edit/validation checks, performs database lock and archive procedures, and establishes database use guidelines
- Remotely monitors Clinical Trials data, confirming data accuracy and quality, and reporting to appropriate stakeholders, as needed.
- Perform supplemental data reviews and reconciliations to support Adverse Event (AE) and safety monitoring.
- Generate and track data queries; work directly with research staff to resolve any issues.
- Develops and maintains Data Management Plans (DMP), Standard Operating Procedures (SOPs), and Work Instructions (WI)
- Assists with the design of data collection, data privacy and confidentiality plans
- Cross-check EDC data against external metrics to verify accuracy and resolve discrepancies
- Recommends operating methods to improve processing, distribution, data flow, collection and database editing procedures, working to optimize data quality and automate data collection and management processes
- Ensures appropriate data use and/or sharing agreements are executed for each project
- Consults with regulatory staff to ensure compliance with all local, federal and Department of Defense specific regulatory policies and procedures
- Maintains working knowledge of all military health system data systems and resources to advise investigators on appropriate data for their research goals
- Assists researchers in retrieving information from military health system databases and other data sources
- Completes other projects and duties as assigned
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