Clinical Trial Supply Assistant

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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.

What You Will Be Doing:

• Primary responsibility is to provide day-to-day operational & administrative support to Clinical Trial Supply Manager (CTSM).

• Support CTSM with upstream packaging/labelling activities, downstream logistics activities and end to end tracking & oversight.  This includes (but not limited to) 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, etc.

• Support other CI staff, including SCPs & SCMs with inter-site transfers & other material movements, destruction requests and general administrative tasks

• For a project or a group of studies covering different projects, give support to the Clinical Trial Supply Manager to ensure a proper study conduct and follow-up (audit, inspection, process improvement, …)

• Responsible to 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), give support to 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 and performing period reviews as required

• For each study, define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), ensure alignment with the other stakeholder’s constraints and develops study logistical plan and including detailed schedule and budget.

• Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of CTSAs.

• Develop and maintain the appropriate documentation (SOPs, WIKI, guidance, and training material to support operations) related to logistic processes.

Your Profile:

You will have solid clinical supplies experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• 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.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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