Represents Data Management as the clinical database and data management subject matter expert on Clinical Project Teams through the following:
- Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements
- Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements
- Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions
- Train database End Users (internal and external users) on the database and/or maintain automated database training system
- Capture and maintain Database and Systems training records
- Assists in FDA and Quality audits that involve Clinical Database and Data Management
- Lead development and quality control (QC) of data management documents including data management plans, data review guidelines, and database validation protocols
- Follows and implements data management standards and best practices and assures Standard Operating Procedures are followed for Data Management activities
Contributes To The Development And Maintenance Of Clinical Database Systems, Including EDC, Edit Checks, Reporting, Study Notifications, Security, Etc. Through The Following
- Partner closely with DM Management, Database Developers/Analysts, and Programmers to drive database and system deliverables
- Translate business requirements into technical requirements for eCRFs, edit checks, study notifications and customizations in the study database
- Perform and document functional and/or user acceptance testing on study databases, reports, study notifications, and database customizations
- Ensure that appropriate data validation (edit check) specifications and quality control checks are implemented per study needs
- Effectively communicate with the Clinical Project Team and other key stakeholders regarding the deliverable, including timeline, workaround, etc.
- Partner with other Data Management team members and DM Management to prioritize deliverables
Serves as a data management expert and works with Biostatistics and Programmers to develop, promote, and ensure standards are utilized correctly in the database and system
- Process database accounts and reviews accounts regularly to ensure integrity of database access and security
- Recommend improvements to existing Clinical Data Management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues
Lead Data Cleaning And Data Freeze/lock Efforts For Regulatory Submissions And Other Business Needs As Requested By The Clinical Project Team Through The Following
- Lead data review meetings with the Clinical Project Team and Statistics to identify data cleaning issues and strategize cleaning efforts
- Project plan interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved
- Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities per work instructions and SOPs as applicable
- Design tools and reports to document data review and assist in data cleaning activities
- Lead and document data freeze activities with the Clinical Project team, Biostatistics, and SAS programmer
- Utilize existing tools/reports, SQL, and database UI to identify data issues and drive resolutions with the Clinical Project Team in a timely manner
