Study Start Up Associate

Study Start Up Associate

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.

As a Study Start Up Associate at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

• Preparation and submission of regulatory packages, collection and management of essential documents, and quality review of study documentation

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives

• Experience with site activation activities, MOH/IRB/EC submissions, and ICF country/site customization

• Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools

• Proactively identify and elevate issues that arise related to support SSU deliverables

• Effectively execute against assigned activities within SSU

• Support implementation of standards for global SSU team

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required qualifications and experience:

• BS/BA degree or Associates degree with ≥3 years of experience in the health care field or direct clinical trial related experience.

• Must have knowledge of clinical trial conduct

• Experience with IVDR studies

• General knowledge of drug development and ICH/GCP guidelines

• Requires proven project management skills

• Familiarity with Veeva Vault TMF and Veeva CTMS

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

• Fluent in English.

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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, Life Works, 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 ()