Clinical Data Associate - Australia

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.