Site Partner II (Study Start Up - Regulatory Submissions)

Site Partner II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Site Partner II, you'll provide support across investigator sites in Colombia for study start-up and regulatory submission activities, including responsibilities such as:

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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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.

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