The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.
Requirements
- Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
- Perform data entry for paper-CRF studies, as needed
- Perform quality control of data entry
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- Assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation
- Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
- Create, revise, appropriate versioning and maintain data management documentation
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
- Review and query clinical trial data according to the Data Management Plan
- Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Assist with coordinating SAE/AE reconciliation
- Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
- Assist with SAS programming and quality control of SAS programs used in the Data Management department
- Assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- Present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
