Senior Site Operations Lead (Clinical Trials)

KCR Placement; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions in Indianapolis, Indiana, seeks a Sr. Site Management Associate to support Principal Investigators and site teams through enrollment, maintenance, and close-out of trials. You will enable efficient trial execution, engage sites, and optimize patient recruitment and retention.

The role focuses on site administration, collaboration with PIs, documentation, and use of sponsor systems such as IRT, EDC, and CTMS to ensure compliance and quality across trials.

Qualifications

• Bachelor's degree in life sciences, clinical research, or related field.
• Understanding of clinical trial processes, GCP, and regulatory requirements.
• Knowledge of clinical trial conduct and ICH 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.

Responsibilities

• Serve as the primary contact for site administration and logistics during enrollment and maintenance.
• Collaborate with PIs and study coordinators to troubleshoot technical and administrative activities.
• Ensure timely site support and sustained engagement through communication and follow-up.
• Track and monitor documentation and systems information for compliance and quality.
• Support protocol amendments, mass mailings, and site communications.
• Assist sites with navigation of sponsor systems (IRT, EDC, eTMF, CTMS) and escalate to SMEs as needed.
• Disseminate training materials related to protocol changes or systems updates.
• Field questions and provide refresher guidance on eCRF entries, IWRS, SIP data entry.

Skills

Site coordination

Data management

Regulatory compliance

Communication

Problem solving

Education

Bachelor's degree in life sciences

Tools

Veeva

TMF

Job description

ICON Strategic Solutions in Indianapolis, Indiana, seeks a Sr. Site Management Associate to support Principal Investigators and site teams through enrollment, maintenance, and close-out of trials. You will enable efficient trial execution, engage sites, and optimize patient recruitment and retention.

The role focuses on site administration, collaboration with PIs, documentation, and use of sponsor systems such as IRT, EDC, and CTMS to ensure compliance and quality across trials.