Associate Clinical Data Manager

Works with Data Review Manager in the study start-up and planning, including contributing to the development of the Risk Assessment and Risk Mitigation Plan, Data Management Plan, Central Monitoring Plan and Data Review Plan.  

Translates Clinical Study requirements into technical requirements for eCRFs, edit checks, study notifications and customizations in the study database in close collaboration with other member of the data review team.  

• Able to develop CRF with cross functional support, incorporating appropriate feedback and finalizing the CRF.  

• Able to develop specifications for data  listings for continuous data review, and communicate with data analytics team members through their development and release.  

• Able to work with external non-CRF data, including developing creating Data Transfer Specifications, verification of external data structure for import into the data model.  

• Able to develop edit check specifications to review for illogical, incomplete and inconsistent data including testing and troubleshooting of edits checks.  

• Identifies, analyzes, proposes solutions, and effectively resolves complex data/database structure issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions. 

• Contributes to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, etc. through the following:  

• Partner closely with Data Review Management, Study Database Manager, and Data Analytics and Systems and other Data Review team members.   

• Perform and document functional and/or user acceptance testing on study databases, reports, study notifications, and database customizations. 

• Utilize existing tools/reports,SQL, and database UI to identify data issues and drive resolutions with the Clinical Study Team in a timely manner.  

• Attend Clinical Study Team meetings. 

• Contribute technical expertise to cross functional teams through CRF changes and the impact on databases and propose implementation strategies.   

• Assists in FDA and Quality System audits that involve Clinical Database and Data Management  

Follows data management standards and best practices and assures Standard processes are followed for Data Management activities.  

Contribute to data cleaning and data snapshot efforts for regulatory submissions and other business needs as requested by the Clinical Study Team through the following:  

• Generate database snapshot and prepare datasets for Biometrics.  

• Contribute to data review meetings with the Clinical Study Team and Biometrics to identify data cleaning issues and strategize cleaning efforts. 

• Monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.  

Perform other duties as assigned.