Lead Data Manager for Clinical Trials

hace 2 días

Buenos Aires, Argentina Beeflow A tiempo completo

Lead Data Manager Job Description The 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 regarding clinical data management. Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting. Data Management Coordinate data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, and database lock. Develop and review data management plan, user acceptance testing, and data validation plan/Edit check specifications. Supervise data entry, provide feedback on quality, and resolve data discrepancies/deficiencies. Manage non-CRF electronic data handling, including receiving, archiving, loading, and reconciliation issues. Perform database edits, manual CRF review, and clinical database lock. Design and review CRFs, coding medical data with coding dictionaries, and SAE reconciliation. Document Management Liaison with Document Center regarding maintenance of TMF and eTMF. Quality Control Perform database QC checks and documentation. Prepare and attend internal and client/third-party audits/inspections of Data Management. Follow up on and resolve audit findings pertaining to Data Management. Training Train Assistant Data Managers and project-specific clinical teams in CRF completion. Corporate/Departmental Assignments Preparation/attendance of Investigator Meetings, teleconferences, and client/vendor meetings. Qualifications • College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities. • At least 3 years of experience with full scope of data management responsibilities in international EDC studies. • At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable). • Project data management experience is a plus. • Full working proficiency in English and strong organizational and managerial skills. Additional Information Advance your career in clinical research and develop new skillsets whilst growing with the organization. PSI CRO #J-18808-Ljbffr

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    hace 3 días

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