To lead the team of Clinical Data Managers, assisting the team to perform their roles and responsibilities

Working as process executive for CDM

Was working as data analyst for clinical data management.Review and action queries on an ongoing basis and update database based on the query resolutions.Review Rave Core Configuration against study requirements and assess need for any amendments.Create and maintain project and study Data Entry Instructions.Maintain Data Management related operational data flows.Review reports and take actions as defined in the DMP or eCRF review manualProvide listings for review to… Show more Was working as data analyst for clinical data management.Review and action queries on an ongoing basis and update database based on the query resolutions.Review Rave Core Configuration against study requirements and assess need for any amendments.Create and maintain project and study Data Entry Instructions.Maintain Data Management related operational data flows.Review reports and take actions as defined in the DMP or eCRF review manualProvide listings for review to the Client as per the timelines defined in the DMP and handle discrepancies found from reviews Perform ongoing and final consistency checks, review protocol deviation handling document and data listings to ensure that all data have been handled appropriately according to the DMP and eCRF Review Manual.Produce list of protocol deviations if any using standard template/reportsPerform corrections post database lock if any. Document agreed discrepancies that cannot be resolved in Study Master File before clean file declaration. Support Quality control checks for the trail.Ensure delivery of quality outputs.Additional responsibilitiesParticipate in knowledge sharing sessions when applicable.Ensure adherence to Cognizant and Client SOPs.Ensure timely submission of timesheets/ functional tracking spreadsheets.Sending the study status report to the client on every fort night basis. Show less

Regulatory affairs

Quality assurance of articlesCopy-editing and proofingMedical writing of clinical trial data of any therapeutic area-CAN, AFF, PSO, HYP, WOM, MEN etcReviewing latest development in clinical trials around the worldEditing of phase I-IV trialsConducting workshop on latest developmentQuality controlPreparation of error log filesInternet searchTraining program- Conducting training for clinical trial insight projectMeeting with clientsQuery solutions of… Show more Quality assurance of articlesCopy-editing and proofingMedical writing of clinical trial data of any therapeutic area-CAN, AFF, PSO, HYP, WOM, MEN etcReviewing latest development in clinical trials around the worldEditing of phase I-IV trialsConducting workshop on latest developmentQuality controlPreparation of error log filesInternet searchTraining program- Conducting training for clinical trial insight projectMeeting with clientsQuery solutions of teamAssisting in conducting technical interviewPreparation of modules of trainingPreparation of Slides for team meeting, Workshops and Company reviewsClient reviewsProject2: Medical WritingDrug and disease managementJob Description:Extraction of dataCompilation of dataEditing of articlePreparation of tablesPreparation of statistical figuresPreparation of ReferencesProof readingQuality assurance of article Show less