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Data Manager Clinical Trials Professional

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina PSI CRO AG A tiempo completo

Clinical Data Manager Role Overview

We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our team at PSI CRO AG. As a key member of our clinical operations team, you will be responsible for ensuring the accuracy and completeness of clinical trial data.

  • Main Responsibilities:
  • Database set-up, testing, maintenance, and data entry
  • Data management communication with clients, project teams, and vendors
  • Study document review, design, and development of project-specific guidelines and instructions
  • eCRF, Data Management, and Data Validation Plan design, and EDC database testing
  • Data entry, follow-up, and validation, including manual CRF review and SAE reconciliation
  • Medical data coding
  • Database lock metrics tracking and reporting
  • CRFs/queries processing, dispatch, and archiving coordination
  • Clinical Data Management working files maintenance
  • Database QC checks, audit preparation, and attendance
  • Site staff and project team training on CRF completion and data management topics

Essential Qualifications:

  • College/University degree (Life Science, Pharmacy degree is a plus)
  • Demonstrated experience in clinical or medical data management
  • English language proficiency
  • Clinical Data Management system experience (e.g. Medidata Rave, Oracle InForm)
  • MS Office application proficiency
  • Organizational and time management skills
  • Independence and multitasking ability