- Responsible for processing complete Study
- Evaluating Team quality and submitting an improvement area to Mangers for course correction.
- Providing Inputs regarding CDM Activities to all stakeholders, of study assigned.
- Guiding Team on Automation for the smooth accomplishment of work.
- Preparation and QC of the eCRF specification of the team members.
- Study and Review protocols & CRF’s
- Preparation and Review of Data Validation Specification (DVS).
- Preparation and review of manual listing of the study
- Preparation and review of eCRF Completion guidelines
- Preparation and review of Data Management Plan (DMP)
- Create and review of the test scripts for the UAT (User Acceptance Testing)
- Performing UAT of the edit checks and screens review of the study.
- Performing the Data Management activities of the studies like query management which includes query generation and query resolution.
- Performing external data reconciliations (SAE and Lab data).
- Generating metrics reports/study status reports for the DM status of the study and updating the stakeholders of the study.
- Documentation of the study activities as per SOP and regulatory guidelines.
- Freezing and Locking of the database.
- Assisting team in all Data Management activities for the assigned studies and helping in other study UAT and closeout activities when required.
- Performing the Post-production changes and assessing the impact of the changes.
- Decision-making capabilities in providing the DM related solution to the study team as applicable.
Qualification: Appropriately Qualified
Experience: 1-3 Years