Site specialist (Icon)

Roles and Responsibilities

What You Will Be Doing:

• Manage vendor access and activation activities, coordinating with external vendors (eCRF, IVRS) and internal stakeholders.

• Handle CDP and submission documentation, ensuring accuracy and compliance throughout the activation process.

• Maintain and update study trackers, ensuring all activities and milestones are accurately captured.

• Collaborate closely with Site Partners, CRAs, IHCRAs, and CTAs to optimize study performance and ensure timely activation.

• Work with cross-functional teams to forecast and track Site Activation plans, ensuring accuracy within ICON’s systems.

• Participate in internal study review meetings to support risk identification, mitigation, and action planning for site activation.

• Ensure Trial Master File (TMF) completeness and quality through timely submission and quality control review.

• Apply proficient knowledge of ICON SOPs/WPs, ICH/GCP, and applicable country regulations/guidelines to ensure compliance across all activities.

• Perform other duties as assigned to support broader project or departmental goals.

Your Profile:

• Bachelor’s degree in Life Sciences or a related discipline.

• Minimum 3 years of experience in clinical research, site operations, or clinical documentation management.

• Solid understanding of the clinical trial process, including documentation and site activation workflows.

• Familiarity with vendor systems (eCRF, IVRS) and administrative coordination.

• Strong organizational and documentation skills with attention to detail.

• Ability to collaborate effectively with multiple stakeholders in a fast-paced, matrixed environment.

• Working knowledge of ICH-GCP guidelines, regulatory requirements, and internal SOPs/WPs.