Study Start Up- Lead at ICON plc

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

0.0

Posted On

16 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Start-Up, Ethics Submissions, Regulatory Submissions, Cross-functional Collaboration, Clinical Trials, Informed Consent Forms, Regulatory Authorities, IRBs/IECs, Vendor Coordination, Import/Export, Supplies Management, Document Archiving, Process Improvement, Mentorship, ICH-GCP, Budget Development

Industry

Biotechnology Research

Description

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

The Study Start-Up Lead will be responsible for leading and managing country-level submissions and approvals for assigned clinical studies, including preparing and reviewing local study documents. This role involves coordinating with regulatory authorities, IRBs/IECs, local vendors, and internal teams to ensure timely study start-up aligned with global expectations.