Mohnisha Manke's Linkedin Analytics

-pursuing diploma in Clinical Research, Clinical Data Management, pharmacovigillance, medical writing course from Clini India,Pune From November 2023 • Knowledge of trends in healthcare industry well known about roles and responsibilities of Clinical Research Coordinator (CRC), Clinical Data Management ( CDM), clinical Research associate (CRA), Clinical Trial Management system (TMF,e TMF),skills of schedule Y, adverse events(AE), & adverse drug reaction(ADR) reporting guidelines MeDRA & medDRA coding guidelines, case triaging, source document writing. • Knowledge of Good Documentation Practice (GDP) audits & Inspections. • Well known about all trials related essential documents (e.g : protocol, ICF,ISF,CRF, IB, TMF, etc) • well known about ICH E6 guidelines for Good clinical practice, Ethical guidelines (IRB/IEC)& guidelines of regulatory Authorities