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, robust 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 environment
- 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 explicit 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 opportunity.

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 opportunity to help build something rather than simply inherit it.

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