Clinical Data Operations Specialist

10 hours ago


Bloemfontein, Orange Free State, South Africa Staff Unlimited Recruitment Pty Ltd TA MPC Recruitment Group EC Full time
Position Overview

Staff Unlimited Recruitment Pty Ltd T/A MPC Recruitment Group EC is seeking a highly skilled Clinical Data Associate to join their team. This individual will be responsible for maintaining and improving performance and quality in data management services, including database set-up, CRF tracking, review, validation, and updating data in clinical databases for paper and EDC studies.

The ideal candidate will assist in the development of data management-relevant study documents and support other team members in data management-related tasks.

Key Responsibilities
  • CRF Tracking and scanning, including set-up and testing of tracking databases
  • Data Entry support where required, and Verification of data entry discrepancies and creation of data entry guidelines
  • Support in database set-up activities for paper and EDC studies, including creation of CRFs, set-up and testing of study databases, creation of test cases for data entry screens, and plausibility checks
  • Validation of CRFs, Queries, and external data
  • Creation and management of queries related to CRFs or external data
  • External data reconciliation
  • Support in quality control tasks for CRF data
  • Participation in team and project meetings
  • Support in TMF-related activities
  • Preparation of data management TMF parts for archiving
  • Support of Clinical Data Managers
  • Process improvements
Optional/Developmental Responsibilities
  • SAE reconciliation
  • User account management
  • User training and related activities for EDC studies
  • Creation and maintenance of external and internal training documentation for EDC studies (general and project specific)
  • Support of eClinical Project Manager
Requirements
  • Education or experience in medical documentation or a related field
  • Knowledge of GCP requirements and understanding of regulatory guidelines in drug research
  • Good computer skills and proficiency with data management software, MS Word, Excel, and the Internet
  • Problem-solving skills and ability to work both independently and in teams
Salary Range

$60,000 - $80,000 per annum, depending on experience and qualifications



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