Clinical Trials Quality Manager (Port Macquarie)

Clinical Trials Quality Manager (Port Macquarie)

31 Oct
|
Mid North Coast Local Health District
|
Port Macquarie

31 Oct

Mid North Coast Local Health District

Port Macquarie

Employment Type: Temporary Part Time (01.02.2027
- 30.01.2028) Position Classification: Health Manager Level 2 Remuneration: $118,821
- $129,511 Hours Per Week: 8 Requisition ID: REQ697018 Applications Close: 3rd November 2026 Locations can be at either Port Macquaire or Coffs Harbour Employment with Mid North Coast LHD requires candidates to hold a valid authority to work in Australia (Aust Work Rights Visa).

What you'll be doing

The Clinical Trials Quality Manager provides oversight of safety, quality and governance systems for clinical trials conducted across Mid North Coast Local Health District (MNCLHD). Embedded within the Research and Knowledge Translation Directorate, the role is responsible for ensuring clinical trial activities are conducted in accordance with the National Clinical Trials Governance Framework (NCTGF), Good Clinical Practice (ICH-GCP), Therapeutic Goods Administration (TGA) requirements, and other relevant regulatory and ethical standards. The position serves as a central point of expertise and accountability for clinical trial quality, supporting consistent, risk-based governance processes across all specialties conducting research within the District. The role supports the growth, sustainability and excellence of MNCLHD's clinical trials program by strengthening compliance, enhancing sponsor confidence, building workforce capability and promoting continuous quality improvement. Working collaboratively with investigators, study coordinators, research governance staff and executive stakeholders, the Clinical Trials Safety and Quality Manager develops and maintains quality systems, audit readiness, monitoring and reporting frameworks, and provides expert advice to support safe, high-quality and efficient clinical trial delivery. Through these activities,



the position contributes to the District's reputation as a leading regional clinical trials site and enables the expansion of complex and high-value research opportunities.

About Y

You possess tertiary qualifications in a healthcare discipline and bring extensive experience in clinical research, particularly in the management and coordination of clinical trials. Your strong understanding of research governance, regulatory requirements, and International Council for Harmonisation Good Clinical Practice (ICH-GCP) principles enables you to support the delivery of high-quality research activities while ensuring compliance with ethical and legislative frameworks. You have demonstrated experience preparing for and facilitating accreditation processes, with a sound understanding of the National Clinical Trials Accreditation Framework and its associated requirements. Your ability to coordinate documentation, engage stakeholders, and ensure organisational readiness contributes to successful accreditation outcomes and continuous improvement in research quality and standards. Your professional background includes conducting audits, analysing findings, preparing comprehensive reports, and implementing practical recommendations that drive measurable improvements. You are skilled at evaluating processes, identifying risks and opportunities, and ensuring evidence-based solutions are effectively translated into practice.



You have a proven track record of leading projects and multidisciplinary teams within complex and fast-paced healthcare environments. Your ability to manage competing priorities, coordinate resources, and maintain focus on strategic objectives allows you to consistently deliver outcomes within demanding timeframes while maintaining high standards of quality and accountability. You are committed to fostering a culture of evidence-based practice and continuous improvement. Through identifying service gaps, evaluating performance, and initiating quality improvement projects, you contribute to enhancing patient care, research excellence, and organisational performance. Your well-developed problem-solving and critical thinking abilities enable you to analyse complex information, make informed decisions, and develop creative solutions. Combined with your strong attention to detail, these skills support effective risk management, quality assurance, and operational efficiency. You are an accomplished communicator with highly developed written and verbal communication skills. You can confidently tailor your communication style to suit diverse audiences, whether preparing detailed reports, presenting information to senior stakeholders, collaborating with multidisciplinary teams, or engaging with research participants and external partners. You thrive in flexible, multi-skilled team environments and is recognised for your advanced interpersonal and customer service skills. Your ability to build productive relationships, support colleagues, and work collaboratively across diverse stakeholder groups contributes to a positive workplace culture and the successful achievement of organisational and research objectiv

📌 Clinical Trials Quality Manager (Port Macquarie)
🏢 Mid North Coast Local Health District
📍 Port Macquarie

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