IxRS/IRT Clinical 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 IxRS/IRT Manager performs all the responsibilities of an IxRS/IRT Manager; however the studies assigned to the IxRS/IRT Manager will generally be of a more complex nature with regards to protocol design and/or medication types. In addition, the IxRS/IRT Manager is required to contribute to process improvements and lead the implementation of new change initiatives related to their activities. They are also expected to support and implement ideas and suggestions for global process improvement efforts. The IxRS/IRT Manager is responsible for training and mentoring other managers where required.

• Member of extended Study Team
• Revises / develops the clinical study protocol regarding identity of study drugs including possible comparators, medical devices, randomization and blinding
• Ensures proper supply of study medication for all patients in a clinical trial by implementing optimal IxRS supply strategies whilst taking risks of partial unblinding into account
• For studies without an IxRS, the IxRS/IRT Manager monitors and assesses clinical supply demands to ensure clinical and clinical supply 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 the process of assessment of the usage of study medication that has been affected by a temperature excursion at site, in co-operation with the Quality-Function, to make certain that no drug whose pharmaceutical quality has been affected negatively can be taken by patients.
• Responsible for expiry date tracking of study medication on the study level and taking of appropriate action in case of study drug expiration to exclude any potential harm of patients caused by taking expired medication. If the shelf life of a batch of study medication can be extended the IxRS/IRT Manager initiates and supervises the process of labeling of medication packs with the new expiry date in accordance with the applicable GMP regulations and legal requirements.
• Supports correct storage as well as drug accountability and supports monitors in destruction of study medication at site.
• Leads the Interactive Voice/Web Recognition System (IxRS) cross-functional sub-team, who has the responsibility for the setup and maintenance of the IxRS System. The IxRS/IRT Manager is accountable for the selection, setup and maintenance of the IxRS 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.
• Performs ongoing vendor management such as performance management and issue resolution at a study level
• Responsible for providing guidance and training to study teams, monitors and site personnel on the handling of study medication and the IXR System.
• Creates and maintains drug handling instructions / Pharmacy manual if required
• Responsible for Training and Mentoring of new IxRS/IRT Managers
• Manages and implementation of the structured Introductory Training Program for new IxRS/IRT Managers.
• Share knowledge and experiences within Development Operations and other relevant stakeholders
• Survey and assess new regulatory developments and develop implementation plan to address new requirements
• Ensure Compliance with all relevant SOP’s, GMP, GCP and ICH guidelines, as well as with legal and ethical standards Member of extended Study Team

• Advanced degree (master’s degree) - Pharmacist degree preferred – with at least 4 years of pharmaceutical industry experience, or bachelor’s degree with 8 years of pharmaceutical industry experience
• Must have at least Two Years of Experience as a IxRS and Medication Manager, or equivalent
• Profound knowledge in drug development
• Knowledge in setting up Interactive Voice/Web Recognition Systems (IxRS)
• Profound knowledge in GCP and GMP matters Excellent project management skills
• 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.