Clinical Trial Oversight Manager – Biotech
Following positive news from its late-stage clinical program and the establishment of a significant commercial partnership with a global pharmaceutical company, this Australian biotechnology business is preparing for its next phase of development.
This newly created role will be the first dedicated appointment outside the executive leadership team.
You will work closely with the COO and senior executives, taking ownership of the day-to-day oversight of the company's clinical trial activities and ensuring its external partners deliver against agreed timelines, budgets, quality standards and regulatory requirements.
This is not a role where you will disappear into a large clinical operations department.
You will have genuine visibility, influence and accountability across the program, with the opportunity to help establish the clinical operating model of a growing biotech.
The opportunity
As Clinical Trial Oversight Manager, you will act as the primary operational link between the company's executive team and its CROs, clinical sites, consultants and specialist vendors.
You will provide sponsor-side oversight rather than completing every activity internally, ensuring the right questions are being asked, emerging risks are identified early and external partners remain accountable for delivery.
Your responsibilities will include:
Providing end-to-end sponsor oversight across ongoing and future clinical studies
Building strong, productive relationships with CROs, clinical trial sites and specialist vendors
Establishing clear governance processes, meeting structures, reporting expectations and escalation pathways
Monitoring study timelines, recruitment, milestones, deliverables and overall program performance
Reviewing CRO and vendor performance against agreed KPIs, contracts, service levels and budgets
Identifying operational risks, delays and quality concerns before they affect critical study milestones




Coordinating cross-functional activities involving clinical operations, data management, biostatistics, safety, medical, regulatory and manufacturing partners
Overseeing site activation, participant recruitment, monitoring activities and study close‐out
Reviewing study documentation, reports, plans and vendor deliverables from a sponsor perspective
Supporting protocol development, study planning and the selection and onboarding of new vendors
Maintaining oversight of study budgets, forecasts, invoices, contracts and change orders
Ensuring studies are conducted in accordance with the protocol, GCP, applicable regulations and internal quality expectations
Supporting deviation management, CAPAs, audits and inspection‐readiness activities
Maintaining appropriate oversight of the Trial Master File and essential study documentation
Preparing explicit clinical program updates for the CEO, executive team, Board and external stakeholders
Helping establish scalable clinical operations systems, processes and controls as the company grows
About you
You will be an experienced clinical operations professional who understands how to oversee a study from the sponsor side and how to get the best from external partners.
You will be comfortable working in a lean environment where priorities can move quickly and where success depends on sound judgement, strong relationships and a willingness to remain close to the detail.
Ideally, you will bring:
Significant experience within clinical operations, clinical project management or trial oversight




Experience working within a biotechnology, pharmaceutical, medical device or CRO environment
Strong knowledge of Phase II or Phase III clinical trials
Demonstrated experience overseeing CROs, sites and clinical service providers
A thorough understanding of ICH‐GCP and the Australian clinical trial setting
The confidence to challenge vendors constructively and hold partners accountable
Strong study planning, risk management, budgeting and problem‐solving capabilities
The ability to interpret operational data and translate it into clear recommendations
Excellent communication skills and the confidence to work directly with senior executives
A practical, collaborative and hands‐on approach
A relevant scientific, healthcare, pharmacy or life sciences qualification
Experience supporting registration‐focused studies, global development programs or regulatory submissions would be highly regarded.
Why consider this opportunity?
This is a genuine ground‐floor biotech prospect.
You will be joining at a time when the business has achieved encouraging clinical progress, secured external commercial validation and is preparing for an important period of growth.
You will have the opportunity to:
Become the company's first dedicated clinical operations hire
Work directly with an experienced executive leadership team
Take meaningful ownership of a pivotal late‐stage clinical program
Shape the systems, partnerships and processes that support future growth
Work across strategic decisions while remaining connected to operational delivery
Make a visible contribution within a business developing technology with significant commercial potential
For someone who has worked within a larger CRO or pharmaceutical organisation and is ready for greater ownership, visibility and influence, this is an chance to help build something rather than simply inherit it.
#J-*****-Ljbffr

📌 Clinical Trial Oversight Manager (Melbourne)
🏢 i-Pharm Consulting
📍 Melbourne