Head of Clinical Trial Operations

Family Doctor Pty Ltd; Australia; On-site; AUD 180,000 - 260,000; Full time

Benefits offered by this job

Flexible working

Travel across network

Job summary

Family Doctor Pty Ltd in Australia is launching a greenfield clinical trials capability across its 110 GP clinics. You will design the operating model, stand up sites, train staff and create a scalable platform that supports ethics, governance and sponsor audits.

The role reports to the executive team, offering direct access to the CEO, national travel, and a unique opportunity to build a new capability from the ground up within a doctor-owned network.

Qualifications

• Substantial clinical research experience across CRO, sponsor or site environments.
• GCP certification and deep working knowledge of ICH-GCP and TGA requirements.
• Proven experience building or running quality systems and SOPs to audit standard.
• Site activation and governance experience - HREC submissions, CTN scheme, site agreements.
• A track record of training and credentialing clinical research staff.
• Experience coordinating across multiple sites or programs.

Responsibilities

• Design and implement the quality management system, SOPs and governance framework to sponsor-audit standard.
• Establish site activation across the network - ethics and governance submissions, CTN scheme requirements, site agreements, indemnity and insurance.
• Build a flagship model: a first cohort of high-capability trial sites, with a wider feeder network behind them.
• Train and credential practice staff as coordinators, and GPs as investigators and sub-investigators.
• Own delivery - recruitment performance, data quality, protocol compliance and sponsor audit outcomes.
• Specify systems requirements (CTMS/eCRF) and integrate trial workflow with our clinical software without disrupting clinic throughput.

Skills

Clinical research experience

GCP certification

ICH-GCP knowledge

TGA requirements

Quality systems

SOPs governance

Site activation

HREC submissions

Training and credentialing

Cross-site coordination

Job description

Build a national clinical trials capability from the ground up

Family Doctor is Australia's largest 100% doctor-owned medical group - around 110 GP clinics across Victoria, Queensland, New South Wales, South Australia, Western Australia and the ACT, performing 3.5 million consultations per year.

We are establishing clinical trials as a core capability across that network, and we're looking for the person who will build it. This is a rare greenfield role: you will design the operating model, stand up the sites, train the people, and create something that doesn't yet exist - at a scale very few organisations in the country can offer.

The commercial and sponsor relationships are led from within the executive. Your mandate is to build the operational engine that delivers trials to the highest standard, and to scale it.

What you’ll own

• Design and implement the quality management system, SOPs and governance framework to sponsor-audit standard
• Establish site activation across the network - ethics and governance submissions, CTN scheme requirements, site agreements, indemnity and insurance
• Build a flagship model: a first cohort of high-capability trial sites, with a wider feeder network behind them
• Train and credential practice staff as coordinators, and GPs as investigators and sub-investigators
• Own delivery - recruitment performance, data quality, protocol compliance and sponsor audit outcomes
• Specify systems requirements (CTMS/eCRF) and integrate trial workflow with our clinical software without disrupting clinic throughput

What you’ll bring

Essential

• Substantial clinical research experience across CRO, sponsor or site environments
• GCP certification and deep working knowledge of ICH-GCP and TGA requirements
• Proven experience building or running quality systems and SOPs to audit standard
• Site activation and governance experience - HREC submissions, CTN scheme, site agreements
• A track record of training and credentialing clinical research staff
• Experience coordinating across multiple sites or programs

Highly regarded

• Experience with trials in primary care or a GP-network setting
• CTMS / eCRF selection and implementation
• Experience standing up a trials capability, not only operating an established one

What we offer

• A genuine build, not a maintenance role - the operating model, the standards and the team will be yours to shape
• National scale - 110 clinics and 3.5 million consultations pa as your platform from day one
• Base salary with a recurring performance incentive tied to the growth of the trials division. The upside is deliberately weighted to what you build - as the division scales, so does your reward
• Flexible working - location and work pattern are negotiable for the right person (being Melbourne based is an advantage); the role involves travel across the network
• Direct line to the executive - you'll work alongside the CEO, with the autonomy and access to make decisions quickly