Site Partner II (Study Start Up - Regulatory Submissions)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Key Responsibilities:

• Lead the preparation, compilation, and quality review of submission packages for Ethics Committee (EC/IRB) review, ensuring all required documentation is complete, accurate, and submitted within established timelines.
• Develop and execute regulatory strategies for Ministry of Health submissions, including COFEPRIS (Mexico) and other applicable local regulatory authorities, to support efficient approval pathways and study activation timelines.
• Coordinate with internal stakeholders, sponsors, investigator sites, and regulatory authorities to address queries, deficiencies, and requests for additional information arising from Ethics Committee and Ministry of Health reviews.
• Provide regulatory guidance to investigator sites on local requirements, ensuring compliance with applicable regulations, ICH-GCP guidelines, and sponsor expectations throughout study start-up and maintenance activities.
• Monitor changes in local regulatory and ethics requirements, assess potential impacts on study timelines, and implement mitigation strategies to minimize activation delays.
• Maintain complete, accurate, and inspection-ready regulatory documentation within the Trial Master File (TMF) and other applicable systems in accordance with ICON quality standards.
• Support country-specific regulatory intelligence and contribute to process improvements that enhance study start-up efficiency, site engagement, and compliance.

These additions fit naturally with the existing responsibilities and highlight the regulatory strategy and Ethics Committee submission expertise often required in Latin America, particularly for COFEPRIS interactions.

Your Profile:

You will bring relevant clinical research experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent clinical research experience.
• Experience in site-facing roles, site management, or clinical operations within CRO, pharma, or healthcare.
• Strong communication, relationship-building, and problem-solving skills.
• Good understanding of site operations and factors influencing recruitment and quality.
• Organised and proactive, with the ability to manage multiple sites and competing priorities.
• Collaborative team player with a commitment to delivering a high-quality site experience.

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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.

Are you a current ICON Employee? Please click here to apply