• Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy.
• Take responsibility for specific tasks on projects, or acts as the main point
of contact for all the DM deliverables on individual projects.
• Train team members on selected tasks.
• Develop CRFs, Data Management Plan, eCRF filling instructions.
• Develop project specific guidelines, e.g. SAE handling, Medical Coding, Third Party data handling and Universal ruling guide lines documents.
• Develop Edit Checks document.
• Lead UAT activities of Screen Testing & Edit Checks testing.
• Lead Data validation and Query Management.
• Identifying and reporting protocol deviations and violations.
• Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
• If required liaise with 3rd party vendors to clean electronic data.
• Perform Interim and final database QC activities.
• Update all relevant tracking system on an ongoing basis.