The Senior Clinical Packaging Operations Coordinator position at ICON is an exciting opportunity for individuals passionate about clinical research and clinical trial supply management. Located in Poland, this full-time role is a comprehensive career path for professionals looking to make an impactful contribution in the healthcare sector. ICON is recognized as a world-leading healthcare intelligence and clinical research organization, dedicated to fostering an inclusive environment that drives innovation and excellence in clinical development.
Responsibilities
The successful candidate will manage technical content and oversee the delivery of series of activities through Third Party Contractors (TPCs). Key responsibilities include:
Leading external packaging work packages for designated clinical studies, ensuring delivery according to agreed timelines while adhering to quality standards and GMP compliance.
Scoping and defining the technical requirements for outsourced activities, assessing feasibility, risks, timelines, and resource needs in collaboration with internal stakeholders.
Owning technical documentation and ensuring execution readiness by approving batch documentation and label texts.
Acting as the primary liaison with TPCs to align on technical expectations, monitor execution, resolve issues, and escalate risks when necessary.
Driving planning, prioritization, and progress tracking using agreed tools while providing transparent status updates to Clinical Supply Chain (CSC) and other key stakeholders.
Ensuring accurate, complete, and compliant documentation and maintaining data integrity.
Continuously maintaining and reporting relevant performance and delivery metrics for assigned studies.
Required Qualifications and Skills
Candidates applying for the Senior Clinical Packaging Operations Coordinator role must meet specific qualifications:
A deep understanding of the R&D environment, the drug development process, and the packaging of Clinical Trial Supplies.
A high degree of accuracy and attention to detail.
The ability to work independently, recognizing issues, resolving or escalating them as appropriate.
Capability to plan and adjust priorities based on changing demands to meet deadlines.
A continuous improvement mindset, able to propose concrete proposals for enhancing processes.
A professional demeanor, especially when dealing with external TPCs.
Proficient verbal, written, and presentation skills.
Strong collaboration abilities, especially within matrix teams, and the capacity to work across various boundaries.
An appreciation for the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes, with awareness of GMP requirements and standards.
Experience in project coordination and a thorough understanding of the end-to-end clinical supplies delivery chain, including API & DP manufacturing, packaging, and distribution activities.
A commitment to maintaining up-to-date knowledge of clinical supply requirements, standards, and relevant GMP regulations worldwide.
Benefits
Working at ICON comes with a plethora of advantages. The company acknowledges that its success is deeply tied to the quality of its people, focusing on cultivating a diverse culture that enhances high performance and nurtures talent. Key benefits include:
A competitive salary with attractive annual leave entitlements
A variety of health insurance options to accommodate the needs of employees and their families
Competitive retirement planning opportunities ensuring financial security for the future
Global Employee Assistance Programme, providing 24-hour access to a vast network of specialized professionals supporting the well-being of employees and their families
Life assurance and flexible optional country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and subsidized travel passes
ICON prides itself on ensuring inclusion and belonging in its culture and values. It endorses nondiscrimination and harassment-free environments, promising to provide equal consideration to all qualified applicants regardless of race, religion, gender, gender identity, disability, or veteran status. Individuals needing accommodations for any part of the application process or in performing the essential functions of the position are encouraged to make requests.
Application Encouragement
If you find this role intriguing but feel unsure if you meet every qualification, ICON encourages you to apply anyway. You may find that your unique skills and experiences align with what the organization is looking for, whether for this role or future opportunities.
Conclusion
The Senior Clinical Packaging Operations Coordinator position at ICON is a significant role for those who wish to contribute to the betterment of healthcare through clinical trials. With a comprehensive approach to employee satisfaction and development, this role promises not just a job but a chance to excel in the clinical research field. Join ICON’s mission today and be part of shaping the future of clinical development.
This job offer was originally published on himalayas.app
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