Clinical Trials Operations Manager

University of the Sunshine Coast; Sunshine Coast Regional; On-site; AUD 134,000 - 163,000; Full time

Benefits offered by this job

Salary + 17% super

Flexible work arrangements

Athena SWAN Bronze Award

Career development and pathways

Employee Assistance Program (EAP)

Discounted private health insurance

Salary packaging options

Job summary

UniSC Clinical Trials at the Sunshine Coast is seeking a Clinical Trials Operations Manager to lead the Maroochydore site. You will oversee end-to-end trial delivery, ensure regulatory compliance, and manage high-value stakeholder relationships while guiding teams to deliver trials on time and within budget.

The role combines senior operational leadership with hands-on oversight of early phase health volunteer trials, requiring flexibility to travel to sites and work outside standard hours.

Qualifications

• Experience leading complex clinical trial operations.
• Strong regulatory and quality standards knowledge.
• Proven ability to manage multi-disciplinary teams.

Responsibilities

• Lead day-to-day operations of UniSC Clinical Trials at Maroochydore.
• Oversee full clinical trial lifecycle from feasibility to close-out.
• Provide guidance to investigators, sponsors and study teams.
• Lead and support multidisciplinary teams, including coordinators.
• Manage 24-hour clinical trial operations, rostering and on-call arrangements.
• Oversee participant recruitment, scheduling and confinement management.
• Ensure regulatory and safety reporting compliance; manage resources and vendors.
• Contribute to strategic and financial planning.

Skills

Leadership

24/7 operations

Clinical trials

Stakeholder management

Regulatory compliance

Project management

Mentoring staff

Vendor management

Job description

University of the Sunshine Coast – Sunshine Coast QLD

2d ago , from University of the Sunshine Coast

• UniSC Clinical Trials | UniSC Sunshine Coast - NEW CLINIC at Maroochy Private Hospital
• Level 10, $148,551 p.a., plus up to 17% employer superannuation
• Full-time (36.25 hours per week), 3 year fixed-term appointment

The Opportunity

UniSC has established a world‑class clinical trials operation that strengthens regional clinical research capability and delivers innovative, industry‑engaged research with real‑world impact. As our Clinical Trials Operations Manager you will play a pivotal leadership role in ensuring effective, efficient and complaint delivery of early phase health volunteer clinical trials at our flagship location at Maroochydore on the Sunshine Coast.

Reporting to the Deputy Director, this role combines senior operational leadership with hands‑on oversight of complex clinical trial activity. You will lead multidisciplinary teams, manage high‑value stakeholder relationships, and ensure trials are delivered on time, within budget, and to the highest regulatory and quality standards. This is a rare opportunity to shape operations, build capability, and contribute directly to the strategic growth of UniSC’s clinical trials portfolio.

Please note, this role requires flexibility to travel to different clinical trial sites as needed, and to work outside standard business hours to support confinement studies and other time‑sensitive trial activities. You may also be required to participate in a 24/7 on‑call or confinement roster.

For more information, please visit us online: UniSC Clinical Trials

You will

• Lead day‑to‑day operations of UniSC Clinical Trials at Maroochy Private Hospital, ensuring compliance with regulatory, ethical and quality standards;
• Oversee full clinical trial lifecycle from feasibility and set‑up through to close‑out;
• Provide expert guidance to investigators, sponsors and study teams across multiple trials;
• Lead and support multidisciplinary teams, including coordinators and support staff;
• Manage 24‑hour clinical trial operations, including roster development, workforce planning, after‑hours coverage and escalation processes to ensure safe and efficient study delivery;
• Oversee participant recruitment, scheduling and management, including healthy volunteer cohorts and early phase studies requiring intensive monitoring and overnight stays;
• Ensure effective management of participant flow, admissions, confinement periods, clinical procedures and discharge activities within a 24‑hour research environment; and
• Manage resources, vendors and safety reporting, and contribute to strategic and financial planning.

About you

You are an experienced clinical trials leader who thrives in complex, fast‑paced research environments. You bring a strong operational mindset, calm and confident leadership, and the ability to balance competing priorities while maintaining exceptional standards. Comfortable working through ambiguity, you engage effectively with senior stakeholders and guide teams through growth and change. Above all, you are driven by impact and take pride in delivering clinical research that makes a meaningful difference.

You will possess:

• Strong leadership and interpersonal skills with the ability to motivate people and promote a positive team environment;
• Demonstrated experience managing 24‑hour clinical operations, including complex rostering, workforce coordination, on‑call arrangements and operational continuity across extended service hours;
• Proven experience overseeing healthy volunteer and/or early phase clinical trials, including participant recruitment, screening, confinement management and intensive protocol‑driven study activities;
• Versatility and capable of coping with ambiguity and change; can maintain high level of professionalism when working under pressure;
• Detailed working knowledge of ICH/GCP;
• Ability to train, motivate and mentor staff to ensure operational outcomes are met;
• Demonstrated experience with clinical trial project management including proficiency in resource planning and utilisation within a 24‑hour operational environment;
• Exceptional ability to work under multiple, competing deadlines;
• Able to delegate responsibilities effectively to team members; and
• Ability to establish and maintain strong relationships with internal and external vendors.

Don't meet every requirement? At UniSC, we understand that your work and life experiences can be just as valuable. If you're excited about this role but your CV doesn't align perfectly with our position description, we encourage you to apply anyway. You may be just the right candidate for this or one of our many other opportunities.

UniSC is an equal opportunity employer, committed to diversity and inclusion. We encourage applications from all backgrounds, including those with disabilities, women in STEM, First Nations Peoples, and individuals of diverse cultures, genders, abilities, and experiences. We value achievement relative to opportunity and encourage your commentary on your achievements in this context. For additional support during the application process, please contact us at *************@usc.edu.au or call [phone].

Have questions or want to know more? For a confidential discussion, please contact:

Jessica Baird
Deputy Director - UniSC Clinical Trials
Telephone: [phone]***
Email: ******@usc.edu.au

We would love the opportunity to get to know you better, but we know it works both ways. To get to know a little more about us, visit us at: Welcome to UniSC and LinkedIn Life

UniSC values a diverse and talented workforce and invites applications from candidates who already have legal work rights in Australia.

UniSC does not accept unsolicited applications. For agency inquiries, contact *************@usc.edu.au

• Our collaborative, passionate and welcoming culture is what really sets us apart.
• Modern teaching & research facilities.
• Professional development and career pathway opportunities.
• We are a proud recipient of the prestigious Athena SWAN Bronze Award, granted as part of the Science in Australia Gender Equity (SAGE) initiative.
• Flexible work arrangements & generous leave options.
• Salary packing options + 17% Super.
• EAP, fitness passport & discounted private health.