Study Start Up Specialist, Business Operations

ICON; Sydney; Remote; AUD 90,000 - 120,000; Full time

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate to join our sponsor-dedicated team in Australia. You will work in a fast-paced, global environment, supporting the SSU plan for country and site distribution.

Key duties include feasibility assessments, site identification, contract negotiations, regulatory submissions, and ensuring patient safety through informed consent materials. A medical or science background with at least three years’ SSU experience and fluency in the local

Qualifications

• Bachelor's degree or local equivalent in medical/science background.
• At least 3 years of experience or understanding of clinical study start-up requirements.
• Fluency in the local language and English is essential.

Responsibilities

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Education

Bachelor's degree or local equivalent in medical/science background

Job description

Study Start Up Associate II, Home-based in Australia

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Study Start Up Associate to join our diverse and dynamic team. As a Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and executing the plan for country and site distribution. Your expertise and dedication will be essential in efficiently conducting SSU (Study Start Up) activities in the assigned countries, ensuring the smooth initiation and progress of clinical trials.

What you will be doing:

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.

• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.

• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.

• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Your Profile:

• A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.

• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.

• Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.

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