Senior Clinical Packaging Operations Coordinator

Clinical Trial Supply Manager

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 Senior Clinical Packaging Operations Coordinator at ICON, you will be responsible for managing the technical content and delivery of these activities through Third Party Contractors

What You Will Do:

The role scope includes primary and secondary packaging, labelling and distribution activities, and associated supporting activities

Key responsibilities include:

• Lead external packaging work packages for allocated clinical studies, ensuring delivery to agreed timelines, quality, and GMP compliance.

• Scope and define technical requirements for outsourced activities; assess feasibility, risks, timelines, and resource needs with internal stakeholders.

• Own technical documentation and execution readiness: approve batch documentation and label texts, support material flows to TPCs, and perform technical review of completed documentation.

• Act as primary interface with TPCs to align on technical expectations, monitor execution, resolve issues, and escalate risks as required.

• Drive planning, prioritisation, and progress tracking using agreed tools; provide transparent status updates to CSC and key stakeholders.

• Ensure accurate, complete, and compliant documentation and data integrity

• Maintain and report relevant performance and delivery metrics for assigned studies.

 

Your Profile:

Required qualifications and experience:

• Demonstrated understanding of R&D environment, the drug development process, GMP and packaging of Clinical Trial Supplies.

• High degree of accuracy and attention to detail.

• Able to work with minimal support on day to day tasks; will identify issues, resolve or escalate.

• Able to plan, adjust priorities to changing demands to meet timelines.

• Continuous improvement mindset – able to deliver concrete proposals

• Ability to represent the company in a professional manner when dealing with external TPCs.

• Applies effective verbal, written and presentation skills.

• Demonstrates effective collaboration within matrix teams and work across boundaries

• Appreciation of the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes; aware of clinical supply GMP requirements and standards.

• Experience in a project co-ordination

• Full understanding of end to end clinical supplies delivery chain: API & DP manufacturing, packaging and distribution activities.

• Maintains an up-to-date knowledge of clinical supply requirements and standards, GMP and relevant regulations worldwide

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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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