Clinical Supply Operations Specialist

Job description Clinical Supply Operations Specialist ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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. Does not supervise staff.

Education requirements:

Bachelor's Degree Experience and Skills:

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 Work in client office (Warren NJ) 3 days/week Salary target: $85,000 - actual pay based on experience. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Salary Range $62,376.00-$77,970.00 Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients' lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you're as driven as we are, join us. You'll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. Didn't find the role you were looking for? Even if the perfect role isn't available right now, we're always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.