IRT Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The IRT Project Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations and oncology development operations. The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Project Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. The Project Manager continues to assume accountability of the IRT during the system’s life cycle, implementing all required amendments.

The Project Manager is also responsible for implementing the clinical supply chain within the IRT for global clinical studies together with the Clinical Supply Manager and ensures the IRT settings allow for optimal stock of IMP for study sites to allocate to patients. Furthermore, the Project Manager is responsible for IMP drug handling training to external investigational sites and internal functions such as CRAs to ensure regulatory GCP compliance.

Key Tasks & Responsibilities:

• Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding.
• Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies.
• For studies without an IRT, the Project Manager monitors and assesses clinical supply demands to ensure requirements are met. They are also responsible for the supervision of the distribution of clinical supplies from central to local depots and from depots to sites.
• Responsible and accountable for assessing the usability of study medication that has been affected by a temperature excursion at site, in co-operation with QA, to ensure that if a drug’s pharmaceutical quality has been compromised it cannot be taken by patients.
• Responsible for expiry date management of study medication on the study level and for taking appropriate action to prevent patients taking expired medication. If the shelf life of a batch of study medication can be extended, the Project Manager initiates and supervises the process of labeling IMP with the new expiry date in accordance with the applicable GMP regulations and legal requirements.
• Provides guidance on correct storage of study medication according to the applicable Technical Registration Documents.
• Support CRA’s with drug accountability activities.
• Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol.
• Provides input on IRT supplier selection and performs on-going IRT supplier oversight such as performance management and issue resolution for their assigned studies.
• Responsible for providing guidance and training to study teams, CRAs and site personnel on the handling of study medication and the IRT System.
• Creates and maintains drug handling instructions / pharmacy manual if required.
• Ensures compliance with all relevant SOPs, GMP, GCP and ICH guidelines, as well as with legal and ethical standards.

Qualifications & Competencies:

• Bachelor’s Degree or equivalent. Pharmacist degree preferred
• 5 years of relevant healthcare clinical development experience
• Profound knowledge in drug development
• Profound knowledge in setting up Interactive Response (IRT) Systems
• Profound knowledge in GCP and knowledge of GMP
• Excellent project management skills
• Excellent communication skills (including fluent English)
• Excellent presentation skills

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.