ICON plc

Global Study Administrator – GSA

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Poland

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Tech Stack

Google Cloud PlatformVault

About the role

  • Collect, review, and track study documents.
  • Help set up, maintain, close, and archive the Trial Master File (TMF), including regular quality checks.
  • Support the creation and management of study documents, making sure they follow templates and are ready for regulatory publishing.
  • Keep information up to date in tracking systems and communication tools and help team members use these systems.
  • Coordinate and track study materials and equipment.
  • Assist with tracking and reconciling invoices.
  • Provide study metrics and reports for audits and regulatory inspections.
  • Organize and help prepare meetings (study team, monitor, investigator, advisory boards).
  • Communicate with internal and external team members, vendors, and investigators.
  • Prepare and share study-related correspondence and materials for meetings, newsletters, and websites.

Requirements

  • Bachelor’s degree in science or related degree
  • Good understanding of drug development.
  • At least three years’ experience supporting clinical studies (administrative or operational) on a GLOBAL level
  • Experience in Vendor management
  • Knowledge of ICH-GCP principles.
  • Strong technical expertise using TMF, eTMF, CTMS, Veeva Vault etc.
  • Team-oriented approach.
Benefits
  • 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
study document managementquality checksregulatory publishinginvoice trackingstudy metrics reportingmeeting preparationvendor managementTMFeTMFCTMS
Soft Skills
communicationteam-orientedorganizational skills