Serves as the Trial Data Manager on all projects and works with the Project Leads, the Lead Data Managers and the Country heads to ensure that the project is delivered on time, with high quality standards.
- Coordinates and leads the data managers for assigned studies and ensures appropriate allocation and track of assigned work.
- Closely works with the Lead Data Manager, Trial Statisticians, CPO heads globally within and across the process to support and ensure the flexible delivery of assigned tasks.
- Ensures high quality, timely communication and trial information(resources, status of assigned activities, issues) flow to, Project Leads and Team Manager.
- Ensure timely, efficient high quality Data Management deliverable's for trials within the process.
- Provide input, review, and maintenance to global working practices and standards.
- Ensure Audit readiness for all trials assigned.
- Identify and plan training needs of the assigned team members.
- Coordinate with the LDMs and DM team to track, report status and progress of data management for allocated trials and be proactive to ensure smooth and successful achievement of key milestones.
- Provide inputs to ensure consistency and accuracy of Protocol, Data Handling Plan & eCRFs for assigned trials.
- Perform trial start up activities, including testing and UAT of Database, edit check specifications, Export and Import programs for assigned trials.
- Coordinate with Coders, Developers, Third Party Coordinators to ensure that the project timelines and deliverable are met consistently.
- Perform QC as required and monitor efficiency trends and opportunities for
- improvements Assist and guide team members in study conduct and close out activities
- like query management.
- Track study specific metrics and SLA.
- Train study team as on when required.
- Closely works with process management team in development of SOP, SWP's..