Are you a proactive clinical trial professional who thrives in a fast-paced, high-accountability environment? We are seeking a Study Start-Up Specialist to join a dynamic and high-performing team delivering predominantly First-in-Human (FIH) and early phase studies with tight timelines. This role plays a critical part in driving efficient study start-up activities to ensure trials are recruitment-ready on time — or ahead of schedule. About the Role You will take ownership of the end-to-end start-up process, working closely with Sponsors, CROs, internal stakeholders and external vendors to meet — and where possible, reduce — agreed start-up timelines. This is a hands-on role suited to someone confident navigating HREC submissions, budgets, CTRAs and governance processes, while maintaining strong relationships across diverse stakeholder groups. Key Responsibilities Drive HREC submissions from preparation through to approval, managing all related correspondence Prepare all internal documentation required prior to study activation Ensure each trial is recruitment-ready ahead of SIV Coordinate mutually suitable SIV dates with Sponsors, CROs and operational teams Prepare and negotiate study budgets using VR templates and tools, escalating where required Facilitate Executive sign-off of CTRAs and ensure all billable items are captured accurately Coordinate internal document review processes Prepare and finalise vendor work orders and supporting documentation Submit required documentation to Governance for approval Work proactively to meet or reduce Sponsor start-up timelines About You You are organised, commercially aware and confident working in a busy, collaborative team environment with strong personalities. You bring initiative, accountability and a solutions-focused mindset. Essential experience: Experience across clinical trial start-up processes (CRO or site experience — both highly regarded) Exposure to HREC submissions and essential document collection Strong communication skills with internal and external stakeholders Experience supporting or negotiating budgets and CTRAs (desirable but highly regarded) Ability to manage multiple studies with tight deadlines Phase I or First-in-Human experience highly desirable What You’ll Bring A proactive, “can-do” attitude Ability to thrive in a dynamic, high-volume environment Strong attention to detail Confidence engaging directly with Sponsors and CROs Collaborative approach and strong interpersonal skills What’s On Offer Immediate start Salary: Competitive base Super (dependent on experience) Opportunity to gain strong exposure to early phase / FIH trials Work within a supportive but high-performing team If you’re ready to step into a fast-paced start-up role where your initiative and expertise will make a genuine impact, we’d love to hear from you.
