Remote Study Start-Up Associate — Clinical Trials

ICON Clinical Research; United States; Remote; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

Employee assistance program

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate to drive site activation and regulatory submissions, ensuring alignment with GCP/ICH standards. The role involves cross-functional collaboration, tracking project status, and issue escalation.

You will support MOH/IRB/EC submissions, oversee SSU activities, and apply Veeva Vault TMF/CTMS tools while maintaining quality documentation and timelines.

Qualifications

• BS/BA or Associate with ≥3 years in health care or clinical trial related experience.
• Knowledge of clinical trial conduct and regulatory expectations.
• Experience with IVDR studies and ICH/GCP guidelines.
• Proven project management skills and ability to coordinate stakeholders.
• Familiarity with Veeva Vault TMF and Veeva CTMS systems.
• Excellent interpersonal, written and verbal communication in English.

Responsibilities

• Lead site start-up and activation activities with deliverable ownership.
• Prepare and submit regulatory packages; collect essential documents and review study documentation.
• Support SSU day‑to‑day operations to meet goals per GCP/ICH guidelines.
• Coordinate MOH/IRB/EC submissions and site country adaptations.
• Provide up-to-date project status and financial information in tracking tools.
• Identify and escalate issues affecting SSU deliverables; execute assigned SSU activities.
• Support implementation of standards for the global SSU team.

Skills

Clinical trial conduct knowledge

Project management

Interpersonal communication

Written and verbal communication

Fluent English

Education

BS/BA or Associate with ≥3 years in health care or clinical trials

Tools

Veeva Vault TMF

Veeva CTMS

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate to drive site activation and regulatory submissions, ensuring alignment with GCP/ICH standards. The role involves cross-functional collaboration, tracking project status, and issue escalation.

You will support MOH/IRB/EC submissions, oversee SSU activities, and apply Veeva Vault TMF/CTMS tools while maintaining quality documentation and timelines.