Kripendra Singh Email & Phone Number

Gurugram, Haryana, India

Gurugram, Haryana, India

Gurgaon, India

Mumbai Area, India

•Read and understand the study required documents (Protocol, Edit Check Specs, eHelp, etc.)•Read and be trained on organizational and regulatory specific mandatory trainings•Perform study start up, conduct and closeout activities as per clinical trial requirements and deliverables•Creation/review of Data Management Plan, Edit Check Specification, eHelp and Data Review Plan•Perform UAT of reports/listings development, study start up/post production changes done in T&E and edit checks as per required by clinical trial•Identifying failed checks/listings/reports and highlighting it to study lead which also include coordination with programming team for resolution•Perform data entry and QC of data entry. As DE­POC conduct session to educate data entry team regarding updated data entry guidelines andconventions.•Ensure all data entry completion and defects are recorded in data entry tracker•Handling logistics, maintenance & archival of paper CRFs received for data entry•Perform data validation activities, manual review and query management•Perform SAE reconciliation•Perform external data reconciliation (eCOA, ECG, LAB, IxRS)•Perform eTMF review. Attend study status calls to demonstrate study status to study lead and create minutes of meeting•Support and mentor new data managers