Clinical Data Associate - Australia
- Support day-to-day operations of data management projects.
- Provide accurate data acquisition, validation, and reconciliation for clinical studies.
- Assist with data entry, tracking, and communication with project teams.
Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.
Responsibilities:
Member of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate I is responsible for providing accurate data acquisition, data validation and reconciliation to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.
- Data entry of clinical trial data using Clinical Data Management software.
- Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
- Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
- Assist CDM with database testing and edit checks testing as appropriate.
- Assist CDM with data cleaning/validation and reconciliation of external data
- Develop and maintain good communications and working relationships with lead CDMs.
- Assist CDM to create reports, listings, and other output as required during the course of the project.
- May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
- Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.
- Participation in project meetings as requested by CDM.
- Assist with agenda/minute writing for data management teams.
Minimum Qualifications & Experience:
- Graduate in a clinical or life sciences related field.
- Relevant experience/qualifications in allied professions may also be considered.
- Preferably at least six months to one year experience working in the research, pharmaceutical industry or a related field.
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