Australia’s clinical trial landscape is notoriously complex. Each state sets its own requirements, reporting rules, and approval timelines, creating significant challenges for multi-state studies. Oversight by both the Therapeutic Goods Administration (TGA) and National Health and Medical Research Council (NHMRC) adds further layers of regulation, often with overlapping responsibilities. It’s no surprise that nearly 70% of clinical trial leaders report confusion—particularly in studies involving genetically modified organisms or combination therapies, where requirements become even more demanding.
This certified program will provide you with a comprehensive understanding of Australia’s clinical trial regulatory and operational landscape, equipping you with the advanced capabilities required to lead complex studies with confidence. You will gain a deep understanding of the Therapeutic Goods Administration (TGA) clinical trial pathways, including Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes, the National Clinical Trials Governance Framework, as well as the ethical review processes across Human Research Ethics Committees (HRECs).
Beyond regulatory knowledge, this program will build your strategic and practical skills in clinical site selection and activation, adaptive clinical trial design for faster approvals, budget development, GCP compliance, pharmacovigilance and patient recruitment strategies across Australia’s dispersed populations. You will also learn effective methods for adverse events reporting, audit readiness, monitoring multi-site environments, and protocol deviation management. Designed around current industry challenges, the program will show you actionable strategies to streamline trial operations, mitigate operational risks, and enhance the overall quality, compliance, and efficiency of clinical trials conducted in Australia.
Upon successful completion of the program, you will attain Certified Australia Clinical Trials Project Manager (CCT™) designation. This industry-recognized certification will validate your professional credentials to lead and manage complex clinical trials in compliance with Australia regulatory frameworks and ICH-GCP (R3) standards, positioning you as an expert in leading ethical and compliant clinical trial projects.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Pricing & Registration- Experience 3 days of instructor-led live training designed to build advanced competencies in Australia’s clinical trial management, regulatory compliance, and multi-state coordination across the country’s diverse and highly regulated research environment.
- Attain the industry-recognized Certified Australia Clinical Trials Project Manager (CCT™) designation, demonstrating your expertise of the full clinical trial lifecycle in Australia, from CTN/CTA submissions and HREC approvals to monitoring, TMF oversight, safety reporting, and GCP-aligned study close-out.
- Gain practical tools and strategic insights into cutting-edge digital trial technologies, risk-based monitoring, Quality-by-Design (QbD), and data integrity frameworks, and develop the expertise to effectively integrate these advancements into high-quality, compliant clinical trial operations.
- For inquiries, chat with our Program Advisors at advisor@charteredcertifications.com or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Accreditations
This Certified Australia Clinical Trials Project Manager (CCT™) is a mark of excellence and distinction that signifies a fully qualified expert possesses profound expertise in applying Australia’s regulatory frameworks to optimize trial efficiency, ensure patient safety, and maintain compliance across Australia’s complex clinical research landscape. It is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all members. The CCT™ charter is a trademarked charter available only to professionals who have completed and passed this program. The certification is governed and maintained by Chartered Institute of Professional Certifications with over 90,000 members around the world. It is also endorsed by prominent associations and organizations worldwide.
The content of this program has been fully certified and accredited by CPD as adhering to Continuing Professional Principles.
What Can You Expect From This Live Program
Despite Australia’s reputation for high-quality research and a robust healthcare system, nearly 50% of clinical trials experience delays due to fragmented ethics review processes and inconsistent approval timelines across states. Additionally, inconsistent interpretation of regulatory requirements among HRECs and study sites frequently results in repeat submissions and extended review cycles.
This certified program will provide you with the regulatory clarity, operational structure, and practical tools needed to navigate these challenges and deliver trials on time and in full compliance. You will gain a clear understanding of the TGA CTN/CTX pathways, the National Statement on Ethical Conduct, HREC expectations, and the practical application of ICH-GCP E6(R2)/E6(R3) across Australia. The curriculum covers the full clinical trial lifecycle—including planning, feasibility, budgeting, contracting, site initiation, monitoring, safety oversight, quality management, and close-out—ensuring you can manage every stage with confidence.
Through real-world examples, you will build practical competency in Quality-by-Design, risk-based quality management (RBQM), and structured risk mitigation, including identifying critical data, critical processes, and quality tolerance limits. You will also learn how to coordinate cross-functional teams in Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Medical Affairs, while addressing common challenges such as data integrity issues, remote monitoring limitations, and cross-team delays.
The program will strengthen your expertise in informed consent, adverse event reporting, safety reconciliation, and documentation excellence—especially Trial Master File (TMF) integrity and TGA inspection readiness through strong oversight frameworks. You will also gain hands-on experience with monitoring plans, hybrid oversight models, KPI-driven performance management, and end-of-trial responsibilities such as Clinical Study Report (CSR) preparation, archiving, and regulatory notifications.
By integrating regulatory knowledge with operational and project-management best practices, this program prepares you to deliver efficient, high-performing, and inspection-ready clinical trials across Australia’s complex research environment.
Upon successful completion, you will attain the Certified Australia Clinical Trials Project Manager (CCT™) designation, a globally recognized certification that validates your professional competence to lead, manage, and oversee complex clinical trials in compliance with HREC, and ICH-GCP (R3) standards. This industry-recognized certification has lifelong validity and positions you as a trusted leader in the Australia clinical research and project management.
Key Skills You Will Gain
- TGA CTN/CTX Mastery
- Multi-HREC Submission Management
- Ethics Review Navigation
- ICH-GCP E6(R2/R3) Compliance
- Risk-Based Monitoring (RBM)
- Quality-By-Design (QbD) Application
- Risk-Based Quality Management (RBQM)
- Critical Data Identification
- Protocol Feasibility Assessment
- Trial Budgeting Excellence
- Site Selection Strategy
- Contract & CTA Negotiation
- Vendor & CRO Oversight
- Recruitment & Retention Planning
- Informed Consent Management
- Adverse Event Reporting
- Safety Data Reconciliation
- TMF Management & Integrity
- Audit & Inspection Readiness
- CAPA Development Skills
- Data Integrity (ALCOA+) Compliance
- Remote & Hybrid Monitoring
- KPI-Driven Performance Oversight
- Cross-Functional Team Coordination
- Monitoring Plan Development
- Protocol Deviation Management
- Project Timeline Optimization
- Clinical Study Report (CSR) Integration
- Stakeholder Communication Strategy
- End-Of-Trial Regulatory Notification Skills
Your Faculty Director
Melinda Borrelli is a distinguished Clinical Research Professional with over 20 years of expertise in Australia's biotechnology industry. Her career encompasses a variety of roles that have cultivated a deep understanding of clinical research complexities, making her an expert mentor in the field.
Proficient in project management, Melinda has demonstrated her expertise through her proficiency in Electronic Data Capture (EDC), Good Clinical Practice (GCP), Clinical Trials, and CRO management. Now a certified vocational Trainer and Assessor, Melinda has transitioned to educating others, drawing on her extensive experience to guide peers through their professional development. She is a compelling presenter, known for engaging and enlightening audiences at both local and international conferences. Melinda Borrelli continues to be a catalyst for growth and excellence in the clinical research field, nurturing new talent and enhancing professional standards through her dynamic leadership and commitment to advancing clinical research practices.
Certified Australia Clinical Trials Project Manager (CCT™) Program Agenda
Chartered Exam
At the end of the program, there will be a Chartered exam comprising 50 multiple choice questions. Upon passing the exam, you will be accredited with Certified Australia Clinical Trials Project Manager (CCT™) designation.
- 98% of students who have taken this exam have passed the exam successfully. Almost all professionals who have taken our courses have passed this test and attain their Certified Australia Clinical Trials Project Manager (CCT™) designation.
- The exam has 50 multiple choice questions and you need to answer 25 out of 50 questions correctly to pass the exam
- You can re-take the exam online as many times as you want, with no additional charges for retaking of exams
- The program cost already includes the exam fees, so there are no additional charges for taking the exam
- If you have challenges passing the exam, you can secure assistance from our team and faculty leader to help you pass the exam.
Certified Australia Clinical Trials Project Manager (CCT™) Designation
Upon completing the program and passing the Chartered exam, you will be awarded with the Certified Australia Clinical Trials Project Manager (CCT™) designation that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally demanded and recognized, this certification demonstrates your expertise in navigating Australia’s complex clinical trial regulatory landscape. It equips you the expertise to manage trial operations, ensure GCP compliance, and uphold the highest standards of ethics, safety, and data integrity. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.
Pricing & Registration
Australia
Dates: 08 - 10 Jun 2026
Venue: Online Executive Program (via Zoom)
Time: 10:00am - 5:30pm Australian Eastern Standard Time (AEST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 30 Mar 2026 | By 11 May 2026 | After 11 May 2026 | |
| Australia Delegates | AUD 2,595 | AUD 2,795 | AUD 2,895 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!
Certified Australia Clinical Trials Project Manager (CCT™)
4.6 (436 ratings)