Ambika G S

Consultant @Eli Lilly and Company

Bengaluru, IN

Develop and maintain user training resources, including job aids, FAQs, and knowledge base articles, to support end-user adoption and effective system use.Utilize ServiceNow to log, track, and resolve Vault Clinical system issues (CTMS) including access issues, milestone roll-up errors, and drug shipment discrepancies by managing incidents (INCs) and requests (RITMs).Perform access reconciliation, conduct data quality reviews, and implement process optimization initiatives to improve system efficiency and compliance.Identify and resolve system integration issues with external vendor platforms; perform root cause analysis and implement preventive measures to ensure long-term system stability.Provide administrative support for Vault Clinical security profile settings, ensuring appropriate user access and compliance with data security policies.Support SAFRNS (Safety Notification System) processes, including:Uploading safety mailings and line listingsConducting quality checksTroubleshooting Okta authentication and site access issuesManaging delegate access and Principal Investigator (PI) EPH ID issues (Enterprise Profile Hub Identifier)Conduct training sessions and mentoring for new joiners, covering system usage, data standards, compliance requirements, and best practices in clinical data operations.Support UAT activities to ensure system functionality aligns with business and regulatory requirements.Assist with internal audits and external regulatory inspections by preparing documentation, gathering evidence, and responding to audit inquiries.

University of Mysore

M.Sc, Microbiology, General