Clinical Supply Operations Specialist

ICON plc • Basking Ridge, NJ

1d • Hybrid

About The Position

Clinical Supply Operations Specialist 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.

Requirements

• Bachelor’s Degree
• Relevant clinical supply management experience within the biotechnology/pharmaceutical industry preferred
• 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 International Council of Harmonization (ICH) / Good Clinical Practices (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

Responsibilities

• Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
• 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.
• 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.
• Provides support in reviewing, tracking and/or archiving IP returns documentation.
• Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
• Facilitates ancillary supply shipments to investigator sites.
• Manages in-house inventory.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• 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
• Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
• Assists with implementing process initiatives in accordance with business needs.
• Tracks metrics related to drug supply processes.
• May assist in training and development as needed.
• Compiles reports of supply status to study teams and clinical logistics team as needed.
• Applies knowledge of company policies and standard practices to resolve problems.
• Does not supervise staff.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level