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.
• What You Will Do: 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 escalate issues that arise related to support SSU deliverables
• Effectively execute against assigned activities within SSU
• Support implementation of standards for global SSU team
• Your Profile: 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.
• #LI-Remote
• #LI-RS1
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

• ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
• Benefits may include: Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable

Retirement and pension plans

• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways
• Benefits may vary depending on role and location.
• Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

• ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
• .
• Are you a current ICON Employee? Please click here to apply