Job
Description
As the clinical database and data management subject matter expert on Clinical Project Teams, your role involves the following key responsibilities: - Attend Clinical Project Team meetings to gather business need requirements and translate them into technical requirements - Partner with other shared service functions like Safety, Core Lab, etc. to gather business need requirements and translate them into technical requirements - Identify, analyze, propose solutions, and effectively resolve complex data issues by 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 - Assist in FDA and Quality audits related to Clinical Database and Data Management - Lead development and quality control (QC) of data management documents such as data management plans, data review guidelines, and database validation protocols - Follow and implement data management standards and best practices, ensuring Standard Operating Procedures are followed - Contribute to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, Security, etc. In addition to the above responsibilities, you will also: - 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 - Communicate effectively with the Clinical Project Team and other key stakeholders regarding deliverables, timelines, workarounds, etc. - Prioritize deliverables in collaboration with other Data Management team members and DM Management - Work with Biostatistics and Programmers to develop and promote standards in the database and system usage - Process database accounts and review accounts regularly to maintain the integrity of database access and security - Recommend improvements to existing Clinical Data Management practices and procedures, including identifying and suggesting solutions for technology issues Your role also involves leading data cleaning and data freeze/lock efforts for regulatory submissions and other business needs: - 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, ensuring timely completion of all data review activities - 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 - 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 promptly This comprehensive role requires you to be a proactive and detail-oriented professional with excellent communication and problem-solving skills, capable of collaborating effectively with cross-functional teams to ensure high-quality data management practices and regulatory compliance.,
