⚡ Accelerate Clinical Trials from Strategy to Green Light
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, and medical device organizations. Our mission is to accelerate the development of therapies that improve patient lives.
Join ICON Strategic Solutions, embedded within a globally recognized, science-driven biopharmaceutical organization at the forefront of innovation.
As a Study Start-Up Lead, you will play a pivotal role in accelerating the delivery of transformative therapies to patients by driving country-level study start-up activities from planning to Green Light. You will work within high-performing global and local teams, champion innovation, and gain exposure to cutting-edge clinical trials in a collaborative, patient-focused environment.
This is a career-defining opportunity for a leader who thrives on ownership, cross-functional collaboration, and operational excellence.
📍 Location: Sydney, Australia – Home-based with occasional office attendance for key meetings.
🏷️ Tags: #LI-KA | #LI-Remote
📋 KEY RESPONSIBILITIES
🎯 Strategic Study Start-Up Leadership
- Lead end-to-end country-level study start-up activities from country allocation to Green Light across assigned projects.
- Prepare, review, and finalize IRB/IEC and Health Authority submissions, including amendments and query responses.
- Ensure timely site selection, activation, and delivery of start-up milestones while maintaining inspection-ready TMF documentation.
🤝 Cross-Functional Collaboration & Innovation
- Partner closely with Global Study Teams, Feasibility Managers, Site Partnerships, and Portfolio Leads to align on timelines and deliverables.
- Drive innovation and efficiency in start-up processes, contributing to continuous improvement and operational excellence initiatives.
- Serve as the primary point of contact for start-up strategy, risk management, and issue resolution within Australia.
👤 YOUR PROFILE
✅ ESSENTIAL REQUIREMENTS
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Proven experience in Study Start-Up / Regulatory Operations within a CRO, pharmaceutical, or biotech environment in Australia.
- Demonstrated leadership experience within trial start-up, including mentoring teams and leading cross-functional initiatives.
- Strong knowledge of ICH/GCP, Australian regulatory frameworks, and ethics committee requirements.
- Ability to manage complex timelines, submissions, and country-level deliverables.
- Excellent stakeholder engagement, collaboration, and problem-solving skills.
- Proactive, solutions-oriented, and able to thrive in a fast-paced, global environment.
🌟 PREFERRED QUALIFICATIONS
- Experience with global study teams and embedded/CRO partnership models.
- Track record of implementing process improvements in study start-up.
- Familiarity with eTMF, CTMS, and electronic submission portals used in Australia.
💼 WHY JOIN ICON STRATEGIC SOLUTIONS?
- Embedded Impact: Work directly within a leading biopharma’s innovation ecosystem while backed by ICON’s global resources.
- Career Growth: Clear pathway to Director-level roles in clinical operations, regulatory strategy, or project leadership.
- Home-Based Flexibility: Enjoy a remote-first role with occasional Sydney office collaboration.
- Cutting-Edge Trials: Gain exposure to novel therapies and complex study designs in a science-driven environment.
- Comprehensive Benefits: Competitive salary, performance incentives, health insurance, retirement planning, wellness programs, and flexible leave policies.
🚀 READY TO LEAD STUDY START-UP IN AUSTRALIA AND BEYOND?
👉 APPLY NOW FOR THE STUDY START-UP LEAD POSITION (SYDNEY-BASED, REMOTE).
ICON is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We encourage all qualified applicants to apply—your leadership and experience are what we value most.
