Clinical Data Operations Specialist
10 hours ago
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
- 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
- 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
$60,000 - $80,000 per annum, depending on experience and qualifications
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