Study Start Up- Lead
- Sydney
- ICON Strategic Solutions
- Clinical Trial Management
- Hybrid
Senior Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
SSU Lead, Hybrid in Sydney
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| FSP leading Global Pharmaceutical Company | Permanent Full‑Time
Location: Sydney (hybrid)
Join a leading global pharmaceutical company as a Study Start‑Up Lead, where you will play a critical role in ensuring the efficient planning, submission, and activation of clinical trials across Australia. This position is ideal for an experienced Study Start-Up professional with strengths in ethics and regulatory submissions in Australia, and cross‑functional collaboration.
You will be working out of the sponsor office in Sydney (~3 days/ week) and have an opportunity to closely collaborate with cross functional study teams.
What you will be doing
- Leading and managing country-level submissions and approvals for assigned clinical studies.
- Preparing, reviewing and coordinating local study documents, including informed consent forms and translations.
- Coordinating with regulatory authorities, IRBs/IECs, local vendors and internal teams to ensure timely study start‑up.
- Ensuring start‑up deliverables and timelines align with global expectations.
- Supporting operational processes such as import/export, supplies management and document archiving.
- Contributing to process improvement initiatives and providing mentorship to colleagues when needed.
Your Profile
- Strong experience in clinical research, including min. 3 years of study start‑up experience within CRO/ Pharmaceutical or Biotechnology company.
- Tertiary qualifications in Life Sciences, Business, or a related discipline.
- Strong understanding of local regulatory requirements, submissions processes and ICH‑GCP.
- Demonstrated experience with budget development, contract negotiation and vendor/stakeholder coordination is advantageous.
- Excellent written and verbal communication skills with strong ability to influence and collaborate.
- Highly organised, proactive and able to manage multiple competing priorities.
- Strong problem-solving skills and the ability to work independently with minimal oversight.
#LI-KA1
#LI-Hybrid
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 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
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 to apply
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
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