Sr. Site Management Associate

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 experience
• Systems experience (Veeva, TMF) highly preferred
• Understanding of the overall clinical development paradigm
• Applied knowledge of customer service and/or project management processes and skills
• Appreciation of/experience in compliance-driven environment
• Effective communication, negotiation and problem-solving skills
• Self-management and organizational skills
• Aptitude to learn and engage in process automation and generative AI
• Ability to streamline processes with technical solutions
• Experience with innovative methodologies to enhance efficiency in clinical research

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

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