Position overview

The Research Operations and Clinical Trials Support Unit provides support for the conduct of clinical research at Canberra Hospital. The Unit currently has active trials in varying stages ranging from ethics submissions to trial close outs. The number of participants in each trial varies from approximately 1 to 1000 participants. These trials are either Pharmaceutical Sponsored trials, Collaborative Groups or Investigator Led trials that are funded by grants such as the National Health & Medical Research Council.

The Clinical Trials Quality Program Manager is a newly established role designed to strengthen the Unit’s quality systems and provide strategic oversight of quality-related initiatives and projects across trials at CHS. This position will work with the Research Operations and Clinical Trials Support Unit (ROCTSU) leadership to strengthen governance, quality, and compliance across all clinical trials coordinated through ROCTSU. The role ensures that CHS trial staff and activities meet the standards required under the National Clinical Trials Governance Framework (NCTGF), the National Safety and Quality Health Service Standards (NSQHS), Good Clinical Practice (GCP), and other applicable regulatory and organisational requirements.

The Clinical Trials Quality Program Manager provides expert guidance, coordination, and oversight of quality management systems, supporting researchers and staff to deliver safe, ethical, and high-quality research that benefits patients and the community. The role will also coordinate projects aimed at enhancing research governance, data integrity, and staff training. This role plays a central part in shaping the Unit’s quality culture, establishing scalable systems, and supporting future service growth.

This position will be instrumental in ensuring that the Unit delivers clinical research of the highest standard, safeguarding participant safety and data reliability while enabling Canberra Hospital to expand its role as a leading clinical research centre.

Key Responsibilities

Specific responsibilities include, but are not limited to, the following:

1. Lead the development, implementation, and monitoring of clinical research quality management systems, frameworks, and procedures that align with CHS strategic priorities and national guidelines.
2. Coordinate accreditation activities under the NCTGF and liaise with external regulators, sponsors, auditors, and accrediting bodies.
3. Provide expert advice and leadership on quality and compliance matters to researchers, clinical trials staff, and management.
4. Monitor and report on quality indicators, risks, deviations, and corrective and preventative actions (CAPA), including escalation to relevant governance bodies.
5. Develop and deliver training, education, and guidance on quality management and requirements to clinical research staff.
6. Foster collaboration across CHS by chairing and/or contributing to quality working groups and representing the Unit at relevent forums.
7. Support vendor and partner management by coordinating audits, qualifications, and quality agreements.
8. Promote a culture of quality awareness, continuous improvement, and consumer engagement across the CHS clinical research program.
9. Undertake other duties appropriate to this level of classification and within the approved scope of clinical practice which contribute to the operations of the organisation.

Competencies

Specific responsibilities include but are not limited to the following.

• Strong leadership and communication skills with the ability to influence, engage, and support diverse stakeholders across research, clinical, and executive teams.
• Advanced knowledge of clinical research governance, GCP, ICH guidelines, and relevant national and international regulatory frameworks.
• Analytical and problem-solving ability, including the capacity to evaluate risks, interpret standards, and implement effective CAPA plans.
• High-level organisational skills with the ability to manage competing priorities in a complex environment.
• Strong interpersonal skills to foster collaboration, partnership, and a positive culture of quality.
• Commitment to CHS values of reliable, progressive, respectful, and kind.

Qualifications

Essential

• Tertiary qualifications in a relevant field

Desirable

• Good Clinical Practice Certification
• Have an understanding of how the National Safety and Quality Health Service (NSQHS) indicators align with this role.

Experience

Essential

• Minimum 1 year working in a quality management role
• Demonstrated experience in quality management within clinical trials, clinical research, or a health-related setting.
• Proven experience in developing, implementing, and maintaining quality systems, including SOPs, policies, and audit programs.

Desirable

• Prior experience in clinical research and/or project management in a healthcare setting
• Experience leading or supporting accreditation, regulatory inspections, and external audits in a clinical research environment.
• Experience providing training, education, and mentoring on quality and compliance.
• Experience engaging with regulators, sponsors, investigators, and governance bodies on quality and compliance matters.
• Experience or knowledge of the CHS Exceptional Care Framework, and all other related frameworks.

Prior to commencement

Appointment to this position is conditional on being granted and retaining appropriate clearances:

• Pre-employment National Police Check.
• Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.

Important information

All employees are required to:

• Adhere to the Canberra Health Services Values and the ACT Public Service Code of Conduct.
• Act in accordance and comply with all relevant Safety and Quality policies and procedures.
• Comply with all relevant clinical and/or competency standards.

CHS is leading the drive to digitally transform health service delivery in Australia through the implementation of a territory wide Digital Health Record. Computer literacy skills are required which are relevant to this role as you will be responsible for completing required documentation and becoming a proficient user of the Digital Health Record and/or other Information Technology systems; once proficient, you will need to remain current with changes, updates, and contingencies.

What you Require (Key Selection Criteria)

These are the key selection criteria for how you will be assessed in conjunction with your resumé and experience and must be addressed in your application:

1. Demonstrated experience in developing, implementing, and monitoring quality and compliance systems in clinical research or a regulated environment, with strong knowledge of GCP and relevant regulatory standards.
2. Proven ability to coordinate audits, inspections, compliance activities, and trial monitoring processes, including managing documentation, audit readiness, and corrective and preventative action plans.
3. Demonstrated ability to plan, organise, and deliver projects, showing high-level leadership, communication, organisational, and motivational skills, with a proven capacity to liaise effectively across all levels of clinical, research, and external stakeholders.
4. Knowledge of and experience with digital tools to support research quality and governance, including proficiency in Microsoft Office (Word, Excel, Power BI, SharePoint) and data management systems, with the ability to apply analytical approaches to support reporting, decision-making, and continuous improvement.
5. Demonstrates understanding of, and adherence to, safety and quality standards, work, health and safety (WH&S) and the positive patient experience. Displays behaviour consistent with CHS’s values of reliable, progressive, respectful and kind.

Work environment description

The following work environment description outlines the inherent requirements of the role and indicates how frequently each of these requirements would need to be performed. Please note that the ACT Public Service is committed to providing reasonable adjustments and ensuring all individuals have equal opportunities in the workplace.