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Job DescriptionThe Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.
Communication Primary communication point for project teams and company departments with regard to clinical data managementCommunication 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:Study documents reviewData Management plan and other project-specific guidelines and instructions development and reviewCo-ordinate/perform user acceptance testingDevelopment of Data Validation Plan/Edit Check SpecificationsData entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issuesData validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of dataNon-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)Database edits (paper CRF studies)Manual CRF review (non-medical checks)Clinical 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 approvalDocument Management Liaison with Document Center with regard to maintenance of TMF and eTMFQuality 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 of Assistant Data ManagersProject-specific training of investigators and clinical team in CRF completionCorporate/Departmental Assignments Investigator Meetings preparation/attendanceMeetings and teleconferences organized by client/vendor preparation/attendanceQualificationsCollege or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilitiesAt least 3 years of experience of full scope of data management responsibilities in international EDC studiesAt least 2 years of experience using CDM/EDC systems (MedidataRave or Oracle Inform preferable)Project data management experience is a plusFull working proficiency in EnglishOrganizational and managerial skillsAdditional InformationAdvance your career in clinical research and develop new skillsets whilst growing with the organization.
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