[Hiring] Clinical Trial Supply Assistant @ICON plc

Role Description

The Clinical Trial Supply Assistant (CTSA) supports the Clinical Trial Supply Manager (CTSM) in the fulfillment of his responsibilities, from set-up to closure of the logistical activities.

• Provide day-to-day operational & administrative support to Clinical Trial Supply Manager (CTSM).
• Support CTSM with:
  • Upstream packaging/labelling activities
  • Downstream logistics activities
  • End to end tracking & oversight
  • Revision of label development contracts
  • Raising study data & label requests
  • Creating packaging & specification orders
  • Raising & tracking depot shipment orders
  • Tracking urgent packaging orders
  • External IRT transactions & site shipment troubleshooting
• Support other CI staff, including SCPs & SCMs with:
  • Inter-site transfers
  • Other material movements
  • Destruction requests
  • General administrative tasks
• Support the Clinical Trial Supply Manager for a project or a group of studies covering different projects to ensure proper study conduct and follow-up (audit, inspection, process improvement, …).
• Encode and maintain the protocol logistical requirements in the logistic demand system (ESR) based on the output of the logistical and randomization kick-off meeting.
• Manage task and purchase orders linked to logistical activities (depot & distribution activities) and support the Clinical Trial Supply Manager on managing logistical study budget.
• Retrieve, analyze data for stock management and propose resupply strategy.
• Perform overall reconciliation of vaccines at study end and ensure proper documentation is available.
• Ensure relevant documentation is archived and posted in the electronic trial master file (eTMF) according to the Reference Model. Perform eTMF tasks including:
  • Uploading relevant artifacts
  • Performing period reviews as required
• Define the operational set-up for each study to align flows, operational strategies, and activities (label creation, label/pack warehouse & distribution) while ensuring alignment with other stakeholders’ constraints and developing study logistical plan including detailed schedule and budget.
• Act as Subject Matter Expert for one or several processes of the team and ensure standard processes and ways of working are in place across all projects and studies for all key activities of CTSAs.
• Develop and maintain the appropriate documentation (SOPs, WIKI, guidance, and training material) related to logistic processes.

Qualifications

• Bachelor's degree in a relevant field, such as pharmacy, life sciences, or supply chain management.
• Proven experience in clinical supplies within the pharmaceutical or biotech industry.
• Strong understanding of regulatory requirements related to clinical trial supply management.
• Excellent organizational and communication skills, with the ability to guide cross-functional teams and drive project success.
• Problem-solving mindset, with the ability to adapt to changing project dynamics and implement effective solutions.

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