Study Start Up Specialist, Business Operations

ICON Strategic Solutions; Australia; Remote; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme (

Life assurance

Country-specific benefits including, e

Job summary

ICON Strategic Solutions seeks a Study Start Up Associate II, home-based in Australia, to support SSU activities across the country within a sponsor-dedicated model. You will work with the Study Start Up Team Lead to develop and execute plans for country and site distribution, and to drive efficient initiation of clinical trials.

You will conduct feasibility assessments, site identification and contract negotiations, coordinate regulatory submissions, and ensure patient safety and compliance

Qualifications

• Bachelor's degree or local equivalent in medical/science field.
• At least 3 years of SSU experience.
• Fluency in English and local language.

Responsibilities

• Efficiently drive SSU activities including feasibility assessments, site identification and site contracts.
• Provide SSU expertise to Study Start Up leads and project teams to drive success.
• Prepare and coordinate regulatory submissions to ethics and regulatory bodies.
• Assist in development and review of master and country-specific ICFs and ensure patient safety and informed consent.

Skills

SSU experience

Clinical research

Regulatory knowledge

Team collaboration

Education

Bachelor's degree in a relevant field

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.

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