Niranjan S N Email & Phone Number

· Experienced in different stages of data management activities for study startup, conduct and closeout in different phases (Phase I to Phase IV)· Familiarity of regulatory requirements for clinical trials in adherence with ICH-GCP guidelines.· Manage and oversee clinical data management activities for multiple clinical trials.· Develop data management plans, data validation specifications, and other study-related documents and maintaining eTMF documents.· Experienced in EDC system validation including Veeva CDMS, CDB, Inform, Medidata Rave Generate, resolve, and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database (PPC).Establishing strong communications with Data Operations Team, Functional Leads, Project Managers and all other stakeholders to ensure appropriate process set-up and following.Assist with the reconciliation of third-party vendor data (eCRF, eDiary, specialty laboratory, IWRS, imaginary etc.)Assist in the development and testing of data management system and discrepancy listings.Conduct database testing and validation to ensure data integrity.Managing clinical data transfer for reviews (IA, safety review, etc)Responsible for delivering accurate data for clinical trial submission.Mentoring, training of data management activities and tools during onboarding of new team members.