Clinical Data Management Specialist

20 hours ago

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

Job Summary

We are seeking a highly skilled Clinical Data Associate to join our team at Staff Unlimited Recruitment Pty Ltd T/A MPC Recruitment Group EC. The successful candidate will be responsible for maintaining and continuously improving performance and quality in data management services.

Main Responsibilities:

  • Database setup, CRF tracking, review, validation, and updating data in clinical databases for paper and EDC studies.
  • Data entry support where required, verification of data entry discrepancies, and creation of data entry guidelines.
  • Support in database setup activities for paper and EDC studies, including the creation of CRFs, study database setup, test case creation 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 independently and in teams.

Skills and Abilities:

  • Strong communication skills – interpersonal and both verbal and written in English.
  • A flexible attitude towards work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

Estimated Salary: AU$ 60,000 - AU$ 80,000 per annum based on experience and location. Note that this is an estimate and may vary depending on various factors such as industry standards, company policies, and local market conditions.

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