Clinical Data Associate - Australia

Novotech; Sydney; Hybride; AUD 65 000 - 80 000; Plein temps

Résumé du poste

Novotech is seeking a Clinical Data Associate I to support day-to-day data management activities in a hybrid Sydney/Melbourne/Brisbane office setup. The role involves data entry, data validation, and reconciliation to ensure SOP and ICH-GCP standards are met.

You will work with the Biometrics Project Manager, review data queries, track CRF pages, and help with database testing, coding coordination, and progress reporting. A life sciences background with 6–12 months in pharma is preferred.

Qualifications

• Graduate in a clinical or life sciences field.
• Experience in allied professions may be considered.
• Preferably 6–12 months in research/pharma.

Responsabilités

• Data entry of clinical trial data using CDM software.
• Assist in review of data queries with sponsor staff.
• Track CRF pages and data queries.
• Support database testing and edit checks testing.
• Assist with data cleaning, validation and reconciliation.
• Maintain communications with lead CDMs.
• Create reports/listings as required.
• Coordinate coding and electronic data transfers as needed.
• Develop tracking systems for study progress (e.g., Novotrak).
• Participate in project meetings and assist with minutes.

Connaissances

Data entry

Clinical data management

GCDMP

Formation

Graduate degree in life sciences

Outils

CDM software

Description du poste

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.