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
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
- 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
- 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
