Clinical Data Manager

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PSI CRO AG

πŸ“Remote - Kazakhstan

Summary

Join PSI, a leading Contract Research Organization, as a Clinical Data Manager in our expanding Kazakhstan team. This crucial role involves managing clinical research data, collaborating with clients and project teams, and ensuring data quality. The position offers office-based/hybrid work in Almaty or remote work within Kazakhstan. You will be responsible for database management, communication, document review, data validation, coding, and reporting. PSI fosters a supportive and inclusive work environment, making it an ideal place to contribute to groundbreaking advancements in the pharmaceutical industry.

Requirements

  • College/University degree (Life Science, Pharmacy degree is a plus)
  • Prior experience with clinical or medical data
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Organisational and time management skills
  • Ability to work independently and multi-task

Responsibilities

  • Track database set-up, testing, maintenance and data entry
  • Communicate with clients, project teams and vendors on data management matters
  • Review study documents, design and develop project specific guidelines and instructions
  • Design eCRF, Data Management and Data Validation Plans and test EDC databases
  • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
  • Code medical data
  • Track and report metrics leading to database lock
  • Coordinate the processing, dispatch and archiving of CRFs/queries
  • Maintain Clinical Data Management working files
  • Perform database QC checks, prepare and attend audits
  • Train site staff and project teams on CRF completion and data management topics

Preferred Qualifications

Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)

Benefits

Office-based/hybrid in Almaty or remote in Kazakhstan (full-time employment)

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