Analyst, Clinical Data Management

The Analyst, Clinical Data Management (TMTT) will translate Clinical study business requirements into system requirements for the collection and management of data from Clinical trials. Ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues. The successful candidate will conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).

Create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct.
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing, and maintaining project timelines, and communications to stakeholders.
Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations.
Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base.
Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.