Interactive Response Technology (IRT) Manager

Remote - United States

The IRT Manager assumes responsibility for operational execution of the Interactive Response Technology (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 and the usability of the data obtained within the clinical study. As an expert in IRT, the IRT 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 IRT Manager continues to assume accountability of the IRT during the system's life cycle, implementing all required amendments.

The IRT Manager is also responsible for implementing the clinical supply chain within the IRT for global clinical studies together with the Clinical Supply Manager (CSM) and ensures the IRT settings allow for optimal stock of IMP for study sites to allocate to patients. Furthermore, this individual is responsible for IMP drug handling training to external investigational sites and internal functions such as Clinical Research Associates (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 whilst considering risks of partial unblinding.
• For studies without an IRT, the IMM 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 IRT 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. The IRT Manager 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.
• The IRT Manager 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
• The IRT Manager contributes to Expert Working Groups as a team member.

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

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.