Sr. Site Management Associate

ICON San Antonio; Center Square (PA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks program

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Sr Site Management Associate to join our sponsor-dedicated team. You will support enrollment, DBL, and site administration across systems like IRT, EDC, eTMF and CTMS, while partnering with PIs and study coordinators to troubleshoot issues and ensure quality.

The role emphasizes ongoing training, TMF readiness, and SOP/GCP compliance, with a focus on efficient collaboration across monitors, CRLs, and cross-functional teams.

Qualifications

• Bachelor’s degree in clinical research or related field.
• Knowledge of Good Documentation Practices and TMF processes.
• Experience with sponsor-site coordination and regulatory activities.

Responsibilities

• Serve as the primary site admin contact for enrollment, maintenance and DBL.
• Collaborate with PIs and study coordinators to troubleshoot issues.
• Ensure timely site support and proactive follow-up for quality.
• Track documentation and ensure compliance with SOPs and GCP.
• Assist with protocol amendments, communications, and training materials.
• Support site navigation of sponsor systems (IRT, EDC, eTMF, CTMS).
• Field questions and provide refresher guidance on eCRF, IWRS, SIP data entry.
• Maintain TMF documentation and readiness for inspections.

Skills

Good Documentation Practices

Veeva TMF experience

Clinical development knowledge

Education

Bachelor’s degree in clinical research

Tools

Veeva Systems

TMF software

Job description

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.

What You Will Do

• 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 elevate 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.

Your Profile

• Bachelor’s degree with at least 2 years of experience in clinical research
• Knowledge of Good Documentation Practices
• Systems experience (Veeva, TMF) highly preferred

Understanding of the overall clinical development paradigm

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