Gopal K Email & Phone Number

In my role as a Senior Associate at Viatris, I performed assigned complex administrative tasks of clean room monitoring from project/batch execution to completion through Electronic Data Capture systems MODA FDC, SCADA and Document Management in accordance with Standard Operating Procedure, Regulatory Compliance, Good Documentation Practice and applicable regulatory requirements. Coupled with Excellent Communication, strong organization and leadership skills, I excel in ensuring regulatory compliance and possess extensive experience in utilizing electronic data capture software and document management to streamline process and ensure efficiency.Technical Skills:Electronic Data Capture: MODA FDC - Data Acquisition, Data entry, data transfer, data review & verification, reconciliation, resolving discrepancies and result entry.Document Management: Managed and maintained the records of both electronic and paper documentation copies of clean room documents, Real Time Monitoring Records (RTMR), Batch Manufacturing Records (BMR) and Simulation Trial Records (STR). Handling of Document receipt, review, imaging, copying, filing, transfer, storage, archiving, retrieval, retention and disposition of related records.Microsoft: Excel, Outlook, word and PowerPoint.Regulatory Compliance: ICH, Good Clinical Practice (GCP) and 21 CFR PART 11.Clinical Data Management: I have completed a comprehensive course in Clinical Data Management at UDEMY, TMF fundamentals at MONTRIUM, and pharmacology module at CLINILAUNCH RESARCH INSTIUTE gaining extensive knowledge in several key areas crucial for trail-level clinical data execution. My expertise encompasses the creation and implementation of Data Management plan, database structure, CRF, data entry, data validation, data acquisition and resolving data clarifications and discrepancies. I have an excellent foundational understanding of phases I-IV trials, medical terminology, Coding dictionaries (MedDRA and WHODRUG), TMF, eTMF, study start-up, conduct and closeout phases, data collection, data cleaning, data validation flow, database lock (DB lock) and data management. In order to upskill and transit my career into Clinical Research Domain, In CliniLaunch Research Institute, I have enrolled the course ADVANCE DIPLOMA IN CLINICAL RESEARCH which encompasses the six modules: pharmacology, clinical research, clinical data management, medical coding, pharmacovigilance and regulatory affairs.