Clinical Data Associate - Australia

Novotech; Sydney; Hybrid; AUD 55,000 - 75,000; Full time

Job summary

Novotech is seeking a Clinical Data Associate I to support day-to-day data management activities on gated projects, performing in-house data entry and project administration in line with GCDMP and SOPs.

The role is hybrid, with 2 days per week in the Sydney, Melbourne or Brisbane office, and opportunities to contribute to data quality, query management and reporting across studies.

Qualifications

• Graduate in a clinical or life sciences related field.
• Relevant experience/qualifications in allied professions may be considered.
• Preferably at least six months to one year experience in the research, pharmaceutical industry or a related field.

Responsibilities

• Provide accurate data acquisition, data validation and reconciliation to clinical studies.
• Data entry of clinical trial data using Clinical Data Management software.
• Review data queries with sponsor companies/monitoring staff.
• Track CRF pages, data queries and entries.
• Assist with database testing and edit checks testing.
• Assist with data cleaning/validation and reconciliation of external data.
• Develop and maintain relationships with lead CDMs.
• Create reports, listings and outputs during projects.
• Coordinate coding and electronic data transfers and address discrepancies.
• Develop and update systems to track study progress (Novotrak, CRF & query flow, safety reports).
• Provide updates on study progress to CDM and participate in project meetings.
• Assist with agenda/minute writing for data management teams.

Skills

Data entry

Data validation

CDM experience

Communication skills

Education

Bachelor in life sciences

Tools

CDM software

Job description

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 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.