General Manager / Chief Operating Officer - Clinical Trials

One Clinical Research; City Of Melville; On-site; AUD 250,000 - 360,000; Full time

Job summary

One Clinical Research, a leading Perth-based clinical trial site network, seeks a General Manager / Chief Operating Officer to lead operations across oncology and haematology trials and to scale the business.

You will chair the senior management team, drive delivery, governance and sponsor relationships, reporting to Directors while the CFO manages budgeting and forecasting. This is a senior executive role with real authority and impact in cancer research.

Qualifications

• Extensive clinical trials leadership experience (10+ years)
• Strong knowledge of ICH-GCP and Australian trial regulation
• Proven leadership of multidisciplinary teams
• Strong sponsor and stakeholder relationship skills
• Postgraduate qualifications (MBA, MHSM or similar) advantageous

Responsibilities

• Own end-to-end delivery across the study portfolio and ensure studies run to protocol and regulatory standards
• Lead the senior management team including Clinical Operations, Nursing, QA and Study Start-up
• Set operational KPIs and capacity plans, and step in to address delivery risk
• Strengthen governance, quality systems, CAPA and audit readiness with QA
• Develop leadership bench, succession planning and a culture of accountability
• Partner with CFO on business plans, workforce planning and commercial perspectives

Job description

General Manager / Chief Operating Officer - Clinical Trials

One Clinical Research is a leading Perth-based clinical trial site network delivering industry-sponsored studies for sponsors and CROs, with a focus on oncology and haematology therapeutic areas. OCR has a capable senior team operating across clinical operations, nursing, quality, finance, study start-up and sponsor liaison. The business has proven it can deliver. It now needs an experienced operator to run it day to day so it can scale.

As the General Manager / Chief Operating Officer, you will be OCR's most senior operational leader, reporting to the company’s Directors and working side by side with our Chief Financial Officer (CFO). You will lead project delivery, people and commercial relationships, whilst the CFO leads financial strategy, control and reporting.

What you will do

Operations and delivery

• Own end-to-end delivery across the study portfolio, from feasibility and start-up to close-out
• Lead the senior management team: Clinical Operations, Clinical Unit (Nursing), Quality Assurance, Study Start-up/HREC and Clinical Liaison
• Set operational KPIs, capacity and resource plans, and step in where delivery is at risk
• Keep the site inspection-ready, with studies run to ICH-GCP, NHMRC and TGA requirements and sponsor expectations

Sponsors and commercial

• Become the senior management face of the company with sponsors and CROs
• Lead feasibility and study-selection decisions
• Work alongside the Directors and high-profile investigators to build referral pathways and bring in new sponsors and therapeutic areas

Governance and risk

• Strengthen governance, quality systems, CAPA and audit readiness with the QA team
• Put clear delegated authorities and reporting in place so decisions are made at the right level
• Report to the Directors on performance, risk and opportunities

People and culture

• Develop the leadership bench beneath you, including succession planning, recruitment and retention
• Build a culture of accountability, collaboration and continuous improvement

Working with the CFO

• You and the CFO share ownership of the business plan. You run operations, workforce planning and commercial relationships. The CFO runs budgeting and forecasting, financial controls, cash flow and reporting.

About you

• Extensive clinical trials experience, ideally 10+ years, including senior leadership of a trials site, hospital research unit, CRO or sponsor operations
• Strong knowledge of ICH-GCP and Australian trial regulation, ethics and governance, and a current ICH-GCP certificate
• Proven leadership of multidisciplinary teams across clinical, quality, finance and/or administrative functions
• Demonstrated commercial accumen
• Strong sponsor and stakeholder relationship skills, with sound judgement under pressure
• Tertiary qualifications in health, science or business, or equivalent senior experience
• Oncology and/or haematology trial experience
• Experience across Phase I (First-in-human) - Phase IV studies
• Experience in a growth or change environment, and postgraduate qualifications (MBA, MHSM or similar)
• A genuine executive role with real authority and a strong senior team already in place
• Competitive salary and a performance incentive
• Meaningful work in cancer research and patient care at a leading clinical research organisation based in Perth

Unrestricted Australian work rights and a police check are required. Only shortlisted candidates will be contacted.

One Clinical Research is an equal opportunity employer.