Clinical Supply Specialist

Clinical Supply Specialist - Dublin

ICON plc is a world leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Supply Specialist at ICON, you will manage and coordinate clinical supplies activities to support the successful execution of clinical trials.

Responsibilities:

• Supply Planning: Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
• Inventory Tracking & Shipments: Independently initiates IP shipment orders according to supply plans or as requested by Clinical Logistics Manager or Clinical Trial Management team; tracks orders from shipment through receipt at investigator study sites; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites.
• Temperature excursions: Processes, reviews and evaluates temperature excursion reports from clinical sites and communicates stability information and/or product acceptability to clinical trial managers, CROs, and investigator sites.
• Returns & Destruction: Provides support in reviewing, tracking and/or archiving IP returns documentation.
• Expiry Management: Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
• Ancillary Supplies: Facilitates ancillary supply shipments to investigator sites. Manages in house inventory.
• Documentation: Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Study Team Interaction: Interacts with Clinical Study teams to act on specific trial needs. Works with functional groups to provide and receive information required for achievement of individual or team assignments, goals and objectives. Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution.
• Vendor Management: Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
• Process Initiatives: Assists with implementing process initiatives in accordance with business needs.
• Metrics: Tracks metrics related to drug supply processes.
• Training: May assist in training and development as needed.
• Reporting: Compiles reports of supply status to study teams and clinical logistics team as needed.
• Problem solving: Applies knowledge of company policies and standard practices to resolve problems.

Education Requirements:

• Bachelor's Degree

Experience and Skills:

• Relevant clinical supply management experience within the biotechnology/pharmaceutical industry.
• At least 3 years relevant experience in the following fields: Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, or Manufacturing.
• Fundamental knowledge of the clinical drug development process and relevant cross functional partners.
• Fundamental knowledge of ICH/GCP & regulatory guidelines/directives.
• Proficiency with MS Word & Excel.
• Efficient and effective problem solving and time management skills.
• Action oriented with high level of agility and adaptability.
• Collaborates and communicates effectively.
• Excellent organizational skills with highly detail oriented approach.
• Work in client office (Dublin, Ireland) 3 days per week.

Benefits:

• Various annual leave entitlements.
• Range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme (LifeWorks), offering 24 hour access to a global network of independent specialized professionals.
• Life assurance.
• Flexible country specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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. The company is committed to providing a workplace free of discrimination and harassment. If you need a reasonable accommodation for any part of the application process or to perform essential functions, please let us know or submit a request here.

We are committed to inclusion and belonging in our culture and values.