LTM role in Australia. Manage oncology/hematology trials for a top pharma client. Home-based, 3+ yrs exp, prior monitoring & TGA knowledge required. FSP model.
Lead Local Oncology Trials: Embedded with a Global Pharma Leader
ICON plc is a world-leading healthcare intelligence and clinical research organization. Through our Functional Service Partnership (FSP) model, you become an embedded extension of our client's team—a top global pharmaceutical company—while enjoying the career support and community of ICON.
We are seeking an experienced and dedicated Local Trial Manager (LTM) to join our FSP division, working 100% home-based in Australia. In this pivotal role, you will be the primary operational leader for Oncology and/or Haematology clinical trials within the country. You will oversee all local study activities, manage site relationships, and ensure flawless execution in compliance with TGA regulations and ICH-GCP. This is a unique opportunity to drive trial success as a trusted partner to a leading innovator in cancer therapeutics.
Your Mission: The Single Point of Accountability for Local Trial Delivery
As the Local Trial Manager, you will be the central figure responsible for the performance, quality, and compliance of assigned clinical trials within Australia. You will translate global study strategy into effective local execution, managing resources, risks, and stakeholder relationships to deliver on time and to the highest standards.
Key Responsibilities
1. End-to-End Local Trial Management
- Serve as the primary operational lead and single point of contact for assigned clinical trials within Australia, ensuring delivery according to timelines, budget, and quality metrics.
- Oversee day-to-day operations, including site feasibility, selection, initiation, monitoring, and close-out activities.
- Develop and manage the local country operational plan, including patient recruitment strategies and risk mitigation plans.
- Monitor and manage local vendors (e.g., central labs, IRT) to ensure seamless service delivery.
2. Site Performance & Compliance Leadership
- Manage and mentor a team of local CRAs, providing direction, support, and ensuring monitoring quality.
- Build and maintain strong, collaborative relationships with Principal Investigators and site staff to drive performance and resolve issues.
- Ensure all local trial activities comply with ICH-GCP, TGA regulations, and client/ICON SOPs.
- Lead local preparations for audits and regulatory inspections.
3. Stakeholder Engagement & Strategic Execution
- Act as the main liaison between the global study team (client) and local Australian sites and team.
- Provide clear, proactive communication on study status, risks, and mitigations to all stakeholders.
- Analyze local trial data and trends to provide insights and optimize study outcomes.
- Proactively identify challenges and implement effective solutions to ensure successful trial execution.
Who You Are: The Ideal Candidate
You are a proactive, resilient leader with deep hands-on experience in Australian clinical operations, particularly in complex therapeutic areas. You excel at independent leadership within a matrixed environment and are passionate about advancing oncology research.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Nursing, or a related field.
- Minimum of 3-5 years of experience in clinical trial management within Australia, with a strong preference for experience in Oncology and/or Haematology trials. (Note: "one year" in the original is likely a typo for a more senior role; 3-5+ is standard).
- Prior monitoring (CRA) experience is mandatory.
- Proven expertise in managing all aspects of local clinical trial execution with a strong understanding of TGA regulatory requirements.
- Exceptional analytical, problem-solving, and organizational skills.
- Outstanding communication and interpersonal skills, with the ability to influence and collaborate across diverse, global teams.
- Home-based with ability to travel domestically to sites and meetings as required.
Why Join as an FSP Local Trial Manager at ICON?
1. Embedded Impact with Dual Support
- Enjoy the best of both worlds: the focused mission and culture of a top pharmaceutical client, backed by the stability, training, and career framework of a global CRO leader.
- Have a direct, significant impact on the client's prestigious oncology pipeline.
2. Career Growth in a Specialized Model
- Develop a highly specialized career path within the sought-after FSP model.
- Opportunities for advancement into Regional Lead, Clinical Project Manager, or dedicated client leadership roles.
3. Comprehensive Home-Based Benefits
- Competitive salary and performance-based bonus aligned with the pharmaceutical sector.
- Fully supported home office setup and IT package.
- Generous annual leave and flexible working arrangements.
- Premium health insurance and comprehensive benefits package.
- Global Employee Assistance Programme and dedicated FSP line management.
Join a Model Designed for Partnership and Excellence
This FSP role is designed for professionals who thrive in client-embedded environments. We are committed to creating an inclusive workplace and encourage all qualified candidates across Australia to apply.
Ready to lead the local fight against cancer with a global leader?
If you are an experienced trial manager with oncology expertise and a passion for local execution, apply now.
