Sr. Site Management 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 Senior Site Management Associate at ICON, is key in supporting Principal Investigators (PIs) and site teams during the enrollment, maintenance, and close-out phases of clinical trials. As an expert capability, this role is essential to support the enablement of efficient and timely trial execution, strong site engagement, and optimized patient recruitment and retention.
What You Will Do:
Clinical Trial Execution & Site Support
Serve as the primary point of contact for site administration and logistical needs during enrollment and maintenance and Data Base Lock (DBL).
Collaborate closely with PIs and study coordinators to troubleshoot technical and administrative activities and issues flagged directly or indirectly (e.g. through the Clinical Research Liaisons)
Ensure timely site support and sustained engagement through consistent communication, proactive problem-solving, and appropriate follow-up.
Track and monitor documentation and systems information to ensure compliance and quality standards are maintained.
Support protocol amendment releases, mass mailings and communications and providing guidance and documentation as needed.
Assist sites with navigation or troubleshooting of sponsor systems (e.g., IRT, EDC, eTMF, CTMS) and escalate complex issues to system Subject Matter Experts (SMEs).
Support dissemination of training materials related to protocol changes, systems updates, or new tools introduced during enrollment/maintenance.
Field questions and provide refresher guidance to sites on processes such as eCRF entries, IWRS use, SIP data entry.
Regulatory & Documentation Oversight
Support maintenance and update of the Trial Master File (TMF) with essential enrollment and maintenance documentation to ensure inspection readiness.
Ensure documentation of patient-related activities, deviation handling, and site correspondence aligns with GCP and internal SOPs.
Flag inconsistencies or delays in data entry, document completion, or other quality-related indicators for follow-up.
Support sponsor audits and inspections by preparing and providing site interaction documentation as needed.
Operational Efficiency & Collaboration
Collaborate with monitors, CRLs, and cross-functional teams to identify unique and trending needs, operational risks, and site administrative feedback.
Utilize internal tracking tools and systems to ensure real-time visibility into site status/compliance.
Provide input into continuous improvement efforts by sharing insights and feedback from sites.
Prioritize workload based on study milestones, enrollment timelines, and site needs.
Design and implement solutions to create lasting fixes through automation, process change or quality improvements.
Required qualifications and experience
Bachelor's degree in life sciences, clinical research, or a related field.
Understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements.
Knowledge of clinical trial conduct and ICH Good Clinical Practice (GCP).
Experience coordinating site study activities, visits, documents and participant workflows.
Experience maintaining essential records and accurate study system information.
Experience supporting investigators and site staff with study requirements and issue resolution.
Experience reviewing colleagues’ work and providing technical guidance on clinical research site operations.
Preferred qualifications and experience
Bachelor’s degree preferably in a scientific or health related field or a minimum of 5 years equivalent experience
Minimum of two (2) years pharmaceutical industry OR clinical research…