- Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRF's to ensure the required information is captured for statistical analysis. Work with biostatistician and SAS programmers to compile and maintain SAS data dictionary.
- Perform coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager
- Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
- Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Lead interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
- Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Mentor clinical team members by resolving problem and providing DM guidance.