Clinical Trial Manager

PRIMARY DETAIL
- Salary Package: $119,056 to $132,475 p.a. (HEW Level 8) plus 17% super & annual leave loading
- Appointment Type: Full-time, fixed-term 12 month contract
- Location: Macquarie University (Wallumattagal Campus, North Ryde)
- About the Role
We are seeking a motivated and experienced people manager with extensive patient-facing clinical trial experience to lead and develop a high performing team. This is an excellent role for someone with a shared passion for providing best practice clinical trial support and mentoring a team of professionals to deliver the highest standards of patient care and safety.
- As the Clinical Trial Manager, reporting to the Head of the Clinical Trials Unit, you will be responsible for leading clinical trial operations and driving research excellence. Your key responsibilities will include:
Leadership & Strategy- Provide high-level leadership and management to the Clinical Trials Unit (CTU) team.- Foster a collaborative and high-performing culture within the clinical trials workforce.- Develop and implement strategies to enhance efficiency, compliance, and research impact.

Clinical Trial Oversight- Oversee the planning, coordination, and execution of multiple investigator-initiated and industry-sponsored clinical trials.- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.- Implement quality assurance processes and risk management strategies.
- Resource & Stakeholder Management- Resource Allocation: Manage budgets, operational workflows, and resource planning for clinical trials.- People Management: Lead, mentor, and develop a team of Clinical Trial Coordinators and research professionals.- Stakeholder Engagement: Build and maintain strong relationships with investigators, sponsors, ethics committees, and research partners.

This role is perfect for an experienced leader in clinical research who is passionate about advancing high-quality, patient-focused trials in an academic environment.

About You
You are an exceptional leader with deep expertise in clinical trial operations. You thrive in fast-paced environments, demonstrating strong strategic thinking, problem-solving, and team leadership skills.

Essential Selection Criteria- Degree in life sciences, health, or a related field.- Extensive (5+ years) experience in clinical trial site operations, including working as a Clinical Trial Coordinator on industry-sponsored Phase I trials or equivalent.- Strong knowledge of Australian clinical trial regulations & GCP requirements.- A track record of developing capability through mentoring, leading by example and fostering a positive and supportive environment where colleagues feel heard and supported.- Excellent consultation and collaboration skills including a demonstrated ability to develop relationships with diverse range of stakeholders to jointly deliver clinical outcomes.- Experience in project management within a clinical trials environment.

Desirable Selection Criteria- Familiarity with clinical trial databases (e.g., INFORM, Medidata RAVE).- Knowledge of Macquarie University Clinical Trials Unit (CTU) processes.- Knowledge of the University and how relevant functions across the University interrelate.
- How to Apply?

✔ Your CV
✔ A cover letter addressing the selection criteria

** _Applicants must have valid working rights in Australia to be considered for this position._

About Us
The- Clinical Trials Unit

(CTU) at Macquarie University is a leading research hub within the- Faculty of Medicine,
- Health
- and Human Sciences

(FMHHS). Our 70+ team members manage over 140 trials, working closely with Macquarie University Hospital and research centers to advance medical discoveries and improve patient care.

Macquarie University is committed to innovation, collaboration, and real-world impact, fostering a diverse and inclusive workplace where your contributions make a difference.
- Why Join Us?- Make a meaningful impact in ground-breaking clinical research.- Lead a high-performing clinical trials team that values teamwork and innovation.- Flexible working arrangements available, including the option of a 9-day fortnight (compressed work week).

Role Requirements:
✔ Criminal history check
✔ Working with children check
✔ Up-to-date immunisations and vaccinations (Category A)
✔ Good Clinical Practice (GCP) Certificate

Applications Close: Monday 24 March 2025 at 11:59PM (AEDT)
- For role-specific inquiries, contact:
Louise Archer |Clinical Trial Senior Manager, Operations|For general recruitment inquiries, contact:
Mirna Alaaiddin |Talent Acquisition Officer| Applications Close:
24/03/2025 11:59 PM

Diversity and Inclusion
- Innovation and ingenuity thrive at Macquarie University when diversity, equity and inclusion take centre stage. At the University, we embrace a culture where diversity of background, experience and perspective are fundamental to our success.
- We do not discriminate on gender identity, age, cult