Study Start Up Associate

Remote Worker LTD.; United States; Remote; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Incentives

Health coverage

Retirement plan

Life insurance

Employee assistance

Training & development

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate to lead site start-up and activation activities, ensuring regulatory compliance and timely study delivery.

You will prepare regulatory packages, manage essential documents, coordinate with study teams, and drive global SSU standards while maintaining clear communication across stakeholders.

Qualifications

• BS/BA or associate degree with ≥3 years in healthcare or clinical trials.
• Knowledge of clinical trial conduct.
• Experience with IVDR studies.
• General knowledge of drug development and ICH/GCP.
• Proven project management skills.
• Familiarity with Veeva Vault TMF and Veeva CTMS.
• Excellent interpersonal, written and verbal communication skills.
• Fluent in English.

Responsibilities

• Lead site start-up and activation activities with deliverables.
• Prepare and submit regulatory packages and essential documents.
• Support SSU day-to-day operations per goals and GCP/ICH guidelines.
• Coordinate with study teams to support timelines.
• Identify and elevate SSU deliverable issues.
• Support implementation of global SSU standards.

Skills

Site start-up experience

ICH/GCP knowledge

Veeva Vault CTMS

Project management

Fluent English

Education

BS/BA or Associates with ≥3 years healthcare/clinical trials

Tools

Veeva Vault TMF

Veeva CTMS

Job description

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 elevate 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

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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.