Experience with Electronic Data Capture (EDC) systems, dataset creation and maintenance; REDCap data collection/management preferred
Strong statistical and data analysis skills with the ability to investigate data quality issues and communicate findings effectively
Requirements:
Oversees quality assurance of all study databases, proactively tests data to identify integrity issues, and plans solutions based on research goals
Designs and modifies Case Report Forms (CRFs) in response to IRB modifications and protocol changes; develops Data Management Plans (DMPs), SOPs, and work instructions
Author and execute comprehensive User Acceptance Testing (UAT) and validation testing plans to ensure database functionality; defines data edit/validation checks and manages database lock and archiving procedures
Remotely monitors Clinical Trials data, generates and tracks data queries, and collaborates with research staff to resolve issues and ensure data quality for safety monitoring
Job description
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
