Clinical Trials Operations Manager

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

Benefits offered by this job

Flexible work arrangements

Salary packing options

Superannuation 17%

EAP

Discounted private health

Fitness passport

Job summary

UniSC invites applications for the role of Clinical Trials Operations Manager at our Maroochydore site. You will lead day-to-day operations, ensure regulatory and quality standards, and oversee the full lifecycle of early phase clinical trials across multiple studies.

Reporting to the Deputy Director, you will manage 24‑hour operations, rostering, recruitment, and complex vendor relationships, while guiding investigators and study teams to deliver trials on time and within budget in a fast-paced

Qualifications

• Experience leading clinical trials operations with strong regulatory knowledge.
• Ability to manage multiple trials, stakeholders and tight timelines.
• Proven capability to lead 24-hour operations and rosters.

Responsibilities

• Lead day-to-day operations at Maroochydore, ensuring compliance.
• Oversee full clinical trial lifecycle from feasibility to close-out.
• Provide guidance to investigators, sponsors and study teams.
• Lead multidisciplinary teams, including coordinators and support staff.
• Manage 24-hour operations, including roster development and after-hours coverage.
• Oversee participant recruitment and confinement management.
• Ensure participant flow and discharge activities in a 24-hour environment.
• Manage resources, vendors and safety reporting; contribute to planning.

Skills

Leadership

Clinical trials

Regulatory knowledge

Project management

Stakeholder mgmt

Rostering

Budgeting

Team leadership

Job description

• 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 unisc‑[e-mail] or call [phone].

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

• 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.