Global Clinical Study Specialist — Hybrid

ICON Strategic Solutions; Cambridge (Lancaster County); Hybrid; USD 85,000 - 120,000; Full time

Job summary

ICON plc is seeking a Clinical Study Specialist for a hybrid role in the United States. You will organize reports, coordinate meetings, and support TMF, CTMS, and site activation activities. The role requires a Bachelor’s degree and 2+ years in clinical research.

You will work with global trial teams (NA, LAM, EU, APAC, India) and engage in vendor oversight, data preparation, and training material curation. This position offers hybrid office/home flexibility in select US locations.

Qualifications

• Bachelor's degree required.
• Minimum 2 years of industry-related experience.
• Experience supporting global trials (NA, LAM, EU, APAC, India).
• Experience working in TMF, CTMS, SharePoint.
• Excels in written and verbal communications.
• Self-starter, can work independently with minimal oversight, solution-oriented.
• Vendor management/oversight experience a plus.
• Open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA.

Responsibilities

• Organizes and delivers analyzable reports and metrics to the clinical study lead.
• Schedules and coordinates meetings, prepares agendas, materials and minutes for study meetings.
• Collates data for assessments (feasibility and site selection) and reviews site usability database.
• Reviews study documents (informed consent forms, case report forms) and supports SOPs.
• Compiles study manuals and maintains versioning of reference materials.
• Gathers materials for training and investigator meetings.
• Tracks site activation, enrolment and monitoring visits and escalates issues.
• Monitors investigator/site status and supports registry postings.
• Performs TMF reconciliations with study lead guidance.
• Ensures receipt of required reports (e.g., 1572 changes, disclosures).
• Manages SharePoint/shared drives and site contacts.
• Contributes to BDirections and data reviews as needed.
• May oversee third-party vendors and close-out activities.

Skills

PowerPoint

Excel

Communication

Vendor management

SharePoint

CTMS

TMF

Education

Bachelor's Degree

Tools

TMF

CTMS

SharePoint

Job description

ICON plc is seeking a Clinical Study Specialist for a hybrid role in the United States. You will organize reports, coordinate meetings, and support TMF, CTMS, and site activation activities. The role requires a Bachelor’s degree and 2+ years in clinical research.

You will work with global trial teams (NA, LAM, EU, APAC, India) and engage in vendor oversight, data preparation, and training material curation. This position offers hybrid office/home flexibility in select US locations.