Job Description
Study Start-Up Lead, Sydney based preferred
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**Role: Study Start-Up Lead**
**Location:** Sydney (Australia) - home-based with occasional office attendance for business meetings
Join ICON Strategic Solutions, embedded within a globally recognised, science-driven biopharmaceutical organisation at the forefront of innovation.
As a Study Start-Up Lead, you will play a key role in accelerating the delivery of transformative therapies to patients, driving country-level study start-up activities from planning to Green Light. You will work with high-performing global and local teams, champion innovation in start-up processes, and gain exposure to cutting-edge clinical trials in a collaborative, patient-focused environment.
This is a career-defining opportunity for someone who thrives on ownership, cross-functional leadership, and operational excellence, while making a tangible impact on clinical development.
**What You Will Be Doing**
+ Lead country-level study start-up activities from country allocation to Green Light across assigned projects
+ Prepare, review, and finalise IRB/IEC and Health Authority submissions, including handling amendments and responding to queries
+ Ensure timely site selection, start-up milestone delivery, and inspection-ready TMF documentation
+ Partner closely with Global Study Teams, Feasibility Managers, Site Partnerships, and Portfolio Leads to meet timelines and deliverables
+ Implement innovative, efficient start-up processes, contributing to continuous improvement initiatives
**Your Profile**
+ Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (minimum requirement)
+ Proven experience in Study Start-Up / Regulatory Operations within CRO, pharmaceutical or biotechnology clinical research in Australia
+ Demonstrated leadership experience within trial start up , including managing or mentoring teams and leading cross-functional initiatives
+ Strong knowledge of ICH/GCP, regulatory frameworks, and ethics committee requirements
+ Demonstrated ability to manage complex timelines, submissions, and country-level start-up deliverables
+ Excellent stakeholder engagement and cross-functional collaboration skills
+ Proactive, solutions-oriented, and able to thrive in a fast-paced, global environment
+ Passionate about operational excellence, innovation, and patient impact
\#LI-KA
\#LI-Remote
**What ICON can offer you:**
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family’s needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**Role: Study Start-Up Lead**
**Location:** Sydney (Australia) - home-based with occasional office attendance for business meetings
Join ICON Strategic Solutions, embedded within a globally recognised, science-driven biopharmaceutical organisation at the forefront of innovation.
As a Study Start-Up Lead, you will play a key role in accelerating the delivery of transformative therapies to patients, driving country-level study start-up activities from planning to Green Light. You will work with high-performing global and local teams, champion innovation in start-up processes, and gain exposure to cutting-edge clinical trials in a collaborative, patient-focused environment.
This is a career-defining opportunity for someone who thrives on ownership, cross-functional leadership, and operational excellence, while making a tangible impact on clinical development.
**What You Will Be Doing**
+ Lead country-level study start-up activities from country allocation to Green Light across assigned projects
+ Prepare, review, and finalise IRB/IEC and Health Authority submissions, including handling amendments and responding to queries
+ Ensure timely site selection, start-up milestone delivery, and inspection-ready TMF documentation
+ Partner closely with Global Study Teams, Feasibility Managers, Site Partnerships, and Portfolio Leads to meet timelines and deliverables
+ Implement innovative, efficient start-up processes, contributing to continuous improvement initiatives
**Your Profile**
+ Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (minimum requirement)
+ Proven experience in Study Start-Up / Regulatory Operations within CRO, pharmaceutical or biotechnology clinical research in Australia
+ Demonstrated leadership experience within trial start up , including managing or mentoring teams and leading cross-functional initiatives
+ Strong knowledge of ICH/GCP, regulatory frameworks, and ethics committee requirements
+ Demonstrated ability to manage complex timelines, submissions, and country-level start-up deliverables
+ Excellent stakeholder engagement and cross-functional collaboration skills
+ Proactive, solutions-oriented, and able to thrive in a fast-paced, global environment
+ Passionate about operational excellence, innovation, and patient impact
\#LI-KA
\#LI-Remote
**What ICON can offer you:**
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family’s needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
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