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.

This Hybrid role will be based 2 days in the Sydney, Melbourne or Brisbane office.

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 positive 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.

Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional full-service CRO.

With the increasing pace of globalization in drug development, Novotech’s expertise in the vibrant and fast growing Asian region has been instrumental in the success of hundreds of phase I-IV clinical trials from Australia to India.

Headquartered in Sydney, with operations in New Zealand, China, Hong Kong, India, Malaysia, the Philippines, Singapore, South Africa, South Korea, Taiwan and Thailand, Novotech’s service offering has come to be recognized for its quality both by our clients, as well as industry analyst groups.

Source: This is an extract from the company's own website.

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📌 Clinical Data Associate - Australia (Sydney)
🏢 Novotech (Australia) Pty
📍 Sydney