Lead Data Manager for Clinical Trials job opportunity at PSI CRO.

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Date2026-01-24T02:58:59.187Z bot
PSI CRO Lead Data Manager for Clinical Trials
Experience: General
Pattern: Full-time
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degreeGeneral
loacation Buenos Aires, Buenos Aires, Argentina
loacation Buenos Aires, ..........Argentina
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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.  CommunicationPrimary 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 reporting Data ManagementCoordination 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)SAE reconciliationElectronic data transfer (import/export) specifications review and approvalDocument ManagementLiaison with Document Center with regard to maintenance of TMF and eTMFQuality ControlDatabase 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 ManagementTrainingTraining of Assistant Data ManagersProject-specific training of investigators and clinical team in CRF completionCorporate/Departmental AssignmentsInvestigator Meetings preparation/attendanceMeetings and teleconferences organized by client/vendor preparation/attendance

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