Site Partner II
ICON is a general 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.
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.
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📌 Site Partner II (Bogotá)
🏢 IRE
📍 Bogotá