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Clinical Trial Data Administrator Grade 2

- Full time (80hrs/fortnight), 12 months Fixed Term role
- Parkville location, with multiple public transport options available
- Salary range between $69,438 - $76,764 + salary packaging + 12% super + 5 weeks annual leave+ monthly ADO

The Peter MacCallum Cancer Centre (Peter Mac) is a Victorian public health service and a world-leading comprehensive cancer centre, dedicated to excellence across all spheres of clinical care, research and education. We are home to the largest cancer research enterprise in Australia and provide treatment to around 40,000 people with cancer each year. Welcoming staff from diverse backgrounds and experiences is integral to fostering innovation and compassion and delivering the best possible cancer care for our patients.

About the team

Nexomics is a dedicated clinical trial division within the Peter MaCallum Pathology Department. We deliver specialised clinical trial testing for internal stakeholders such as PCCTU and Research teams, under NATA ISO15189 and ISO17025 accreditation. In addition, Nexomics provides central lab services for clinical trials for commercial sponsors, CROs and biopharma companies globally.

About the role

The Clinical Trial Data Administrator is responsible for coordinating, preparing, validating and transferring clinical trial and laboratory data to Sponsors, CROs and other approved external stakeholders in accordance with study-specific data transfer specifications, protocols and regulatory requirements. Working closely with senior scientific staff, the role supports the delivery of high-quality, reliable and compliant datasets that facilitate clinical trial conduct, oversight and reporting.

The position is responsible for extracting, analysing and reporting data from the LIMS, clinical trial databases and other organisational systems to develop KPIs, operational metrics, dashboards and reports for Clinical Trials Operations Manager, and senior staff. These outputs support informed decision-making, performance monitoring and continuous improvement within Nexomics.

A regular day will see you:

- Participate in the development, review and maintenance of study-specific data
- Develop, maintain and distribute routine and ad-hoc KPI reports
- Participate in the implementation of activities in preparation for the new LIMS roll out
- Liaise with internal and external stakeholders

About you

We are seeking a candidate who thrives in a fast-paced, dynamic environment, communicates effectively with both colleagues and external clients, and demonstrates the ability to manage and prioritise multiple tasks with confidence and efficiency.

You’ll bring with you:

- Minimum requirements of Certificate/Diploma in computer science, information technology or data science
- Demonstrated experience in data entry, database management or administration within healthcare environment.
- Advance skills in Microsoft Office Suite and IT systems
- High level of accuracy and attention to detail
- Strong organisational and time management skills with ability to prioritise competing tasks and meet deadlines

We offer a range of benefits which support our people both personally and professionally, including:

- Up to $11,660 in salary packaging to increase your take home pay
- Discounted health insurance and eye care
- A comprehensive health and wellbeing program
- Public transport options at our doorstep and end of journey facilities for cyclists
- Onsite eateries and coffee shops and inviting rooftop garden spaces
- Pathways for professional development and new career opportunities
- Five weeks annual leave, 17.5% leave loading, monthly ADO’s and purchased leave options

Inclusion and belonging

Peter Mac celebrates, values and supports a diverse and inclusive environment which reflects our vibrant community. We encourage applications from anyone identifying as Aboriginal and/or Torres Strait Islander. We also welcome anyone who identifies as LGBTQIA+, linguistically, culturally and/or gender diverse, people with disability, and people of any age to apply for our roles.

Should you need assistance or require any adjustments or accommodations to fully participate in the application or interview process, you are welcome to reach out to the contact person listed. We acknowledge that not all applicants will meet the full list of selection criteria outlined,



and wherever possible we will consider applications where relevant experience can apply.

For a confidential discussion about this role, please contact

Position Summary

The Clinical Trial Data Administrator is responsible for coordinating, preparing, validating and transferring clinical trial and laboratory data to Sponsors, CROs and other approved external stakeholders in accordance with study-specific data transfer specifications, protocols and regulatory requirements. Working closely with senior scientific staff, the role supports the delivery of high-quality, reliable and compliant datasets that facilitate clinical trial conduct, oversight and reporting.

The position is responsible for extracting, analysing and reporting data from the LIMS, clinical trial databases and other organisational systems to develop KPIs, operational metrics, dashboards and reports for Clinical Trials Operations Manager, and senior staff. These outputs support informed decision-making, performance monitoring and continuous improvement within nexomics.

The Clinical Trial Data Administrator also contributes to data reconciliation, quality assurance, retention and archival activities, ensuring study data are maintained in accordance with Good Clinical Practice (GCP), privacy legislation, sponsor requirements and applicable regulatory guidelines. The role plays a critical part in maintaining data integrity, supporting audit and inspection readiness, and enabling the effective and compliant delivery of clinical trials.

Health and Allied Health Services, Managers and Administrative Workers

Classification or Salary Range

Grade 2 (HS2-HS21)

Category C: As this role does not have direct patient contact, employees are strongly encouraged (although not required) to be vaccinated against COVID-19, influenza, whooping cough (pertussis), chicken pox, hepatitis B, and MMR (measles, mumps, rubella).

Key Relationships

Internal

- Clinical Trials Operations Manager
- Senior Clinical Trials Support Officer
- Senior Scientific Officer
- Clinical Trial Coordinator and administrators
- Nexomics senior staff
- Quality Officers
- Business Development team (nexomics)
- Nexomics technical staff

External

- External clinicians and clients
- Sponsors and CROs

Skills

- Minimum requirement of Certificate/Diploma in computer science, information technology or data science.
- Demonstrated advanced skills in Microsoft Office application such as Excel, Word and Outlook.
- Demonstrated experience in data entry, database management or administration within healthcare environment.
- High level of accuracy and attention to detail
- Strong organisational and time management skills with ability to prioritise competing tasks and meet deadlines.
- Excellent written and verbal communication skills.
- Ability to work both independently and collaboratively within a multidisciplinary team and external stakeholders.
- Previous experience working in a clinical trials or clinical research environment
- Experience using LIMS such Auslab, EPIC, Cerner or equivalent
- Knowledge of ICH-GCP
- Understanding of medical terminology

Data Transfer

- Participate in the development, review and maintenance of study-specific Data Transfer Specifications and Data Transfer Agreements (DTAs), in collaboration with sponsors, CROs and senior scientific staff, ensuring deliverables are completed within agreed timelines.
- Prepare, validate and reconcile clinical trial and laboratory datasets to ensure completeness, accuracy, consistency and compliance with study protocols, sponsor requirements and regulatory standards prior to data transfer.
- Coordinate and execute the secure and timely transfer of study data to sponsors, CROs and approved external stakeholders according to approved schedules and data transfer specifications.
- Extract, compile and manipulate data from the LIMS, clinical trial databases and other organisational systems to generate sponsor-ready datasets.
- Perform ongoing data quality checks and resolve discrepancies,



inconsistencies and data-related issues in collaboration with study teams and senior staff.
- Respond to and resolve data queries raised by sponsors, CROs, monitors and internal stakeholders within agreed timelines.
- Maintain accurate records of data transfer activities, dataset versions, approvals and associated documentation in accordance with organisational and regulatory requirements.

KPI Reporting

- Develop, maintain and distribute routine and ad hoc KPI reports, dashboards and operational metrics to support Clinical Trials Operations management and governance activities.
- Prepare performance reports, data summaries for management meetings, sponsors and other stakeholders.
- Maintain reporting tools, databases and data dictionaries to support standardised and reproducible KPI reporting processes.
- Support the development and implementation of current performance measures, dashboards and reporting frameworks to meet organisational and clinical trial business needs.
- Ensure all KPI reporting activities are conducted in accordance with organisational policies, data governance requirements and privacy regulations.
- Respond to requests for operational data, metrics and performance reports within agreed timelines.
- Contribute to the continuous review and enhancement of reporting processes to improve efficiency, data quality and stakeholder access to meaningful performance information.

Learning and development

- Participate in educational activities, including internal and external training programs, scientific meetings, workshops and career development opportunities relevant to the role.
- Maintain and continuously develop specialised knowledge and skills in clinical trial data management, laboratory systems, regulatory requirements and emerging technologies.
- Embrace innovation, process improvement and change initiatives that enhance data quality, operational efficiency and service delivery.

Key Accountabilities (Contd.)

System and Process Implementation and Maintenance

- Participate in user acceptance testing (UAT), validation, and implementation of LIMS, clinical trial databases, and other clinical trial systems.
- Assist with developing and executing test scripts, test cases, and validation activities to ensure systems meet operational, study, and regulatory requirements.
- Support data migration, reconciliation, and verification during system implementations and upgrades.
- Contribute to the development and review of system-related SOPs, work instructions, and user guides.
- Assist with implementing new processes and workflows to integrate systems into clinical trial and laboratory operations.
- Provide user support and participate in training and change management activities during system rollouts.Monitor system performance after implementation and support continuous improvement initiatives to enhance functionality, efficiency, and data quality.
- Maintain validation, testing, and implementation documentation to support audit and inspection readiness.
- Collaborate with stakeholders to gather business requirements and support ongoing improvements to clinical trial and laboratory information systems.

Quality Assurance

- Promptly identify, document and elevate procedural deviations, system issues, data discrepancies, incidents and non-conformances to senior staff, contributing to timely investigation and resolution.
- Participate in quality assurance, quality improvement and compliance activities to support the integrity, accuracy and reliability of clinical trial and laboratory data.
- Ensure all data management, reporting and data transfer activities comply with applicable regulatory requirements, including ICH-GCP, NPAAC guidelines, privacy legislation, institutional policies and study-specific requirements.
- Contribute to data quality review, reconciliation and verification processes to maintain accurate, complete and auditable study records.
- Support audit and inspection readiness by maintaining accurate documentation and complying with approved standard operating procedures (SOPs), and quality management processes.
- Participate in internal and external audits, monitoring visits and corrective and preventive action (CAPA) activities as required.
- Contribute to the development, review and continuous improvement of SOPs, work instructions and reporting processes.

Ethical Conduct and Safety

- Acts in accordance with institution ethical guidelines and those established by

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📌 Clinical Trial Data Administrator (Melbourne)
🏢 Peter MaCallum Cancer Cente - Peter Mac
📍 Melbourne