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Job DescriptionThe Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.
Communication Provide general oversight on all Data Management activities on large complex global studiesCommunication line for clients/vendors for all data management aspects of clinical projects and clinical data management reportingData Management Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:Reviews and approvals, escalation point and troubleshootingInvolved in audits and inspectionsSupporting with SOP development and process improvementsProvide input into Proposals, Budgets and Bid Defense meetingsClinical database lockCoordination and supervision of processing, dispatch and archiving of CRFs/queriesInput into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocolDevelopment of CRF completion guidelinesCoding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)Electronic data transfer (import/export) specifications review and approvalQuality Control Database QC checks performance and documentationShared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data ManagementShared responsibility for follow-up on and resolution of audit findings pertaining to Data ManagementTraining Training junior members of the teamProject-specific training of investigators and clinical team in CRF completionQualificationsCollege or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilitiesSignificant experience of full scope of data management responsibilities in international EDC studiesExperience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)Organizational and managerial skillsAdditional InformationAdvance your career in clinical research and develop new skillsets whilst growing with the organization.
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