IRT Senior Manager Clinical Business Operations - Clinical Systems

Clinical Business Operations-Clinical Systems is a business unit within the Clinical Operations Department. This role will report to the Senior Director of Clinical Operations.

The Interactive Response Technology (IRT) Project Manager [“Project Manager”] assumes responsibility for supporting the operational execution of the IRT system used for Phase I to IV clinical studies in development. 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, overseeing implementation for any required amendments. This will require strong collaboration with the Clinical Operations Study Lead (COSL) and the Quality System & Compliance (QS&C) team members to ensure our IRT system(s) meets compliance requirements.

The Project Manager is also responsible for working closely with Investigational Supply Operations (ISO) to support assurance that the IRT settings allow for the appropriate stock of Investigational Product (IP) for study sites to allocate to patients. The Project Manager will also work with Data Management to support IRT integrations with the Electronic Data Capture (EDC) System.

Further, the Project Manager is responsible for supporting the build-out of this role within the Clinical Systems group. Examples may include: creation of an IRT Playbook that helps study teams understand company standards for IRT technology, acting as the primary contact for the IRT vendor and seeking opportunities to improve the Sponsor-Vendor partnership, nominating and implementation process improvements in the IRT space and keeping the clinical development functions abreast of IRT industry trends and technology solutions. We are looking for an emerging or proven leader who can work independently and has the experience to help the company create a seamless IRT process from vendor selection through system close-out.

• Advises on the development of the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding in relation to IRT operational optimization.
• Acts as a core stakeholder for the selection of the IRT vendor for each project.
• Leads the IRT cross-functional efforts 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.
• Is responsible for reviewing IRT specifications and supports the Clinical Operations Study Lead (COSL) and ISO lead to ensure they understand the specifications.
• Reviews UAT scripts that are prepared by the Quality Systems and Compliance Team for accuracy.
• Participates and may even perform UAT for each study build (inclusive of amendments). Also, determines the amount of staff that is needed to execute the UAT scripts and works with each study team to alert of the COSL/ISO and others are needed to execute UAT.
• Is available to collaborate with ISO to ensure an appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies.
• Performs on-going IRT supplier oversight such as performance management and issue resolution.
• Helps to build IRT Standards within the company so efficiencies are realized.
• Is the primary lead for QS&C for any audits of IRT vendors.
• Is available to provide guidance and training to study teams, on the handling of study medication and the IRT System.
• Collaborates with ISO and the COSL in review of the pharmacy manual (applicable content) elements that affect the IRT system.
• Ensures compliance with all relevant SOPs, GCP and ICH guidelines, as well as with legal and ethical standards.

Requirements:

• Bachelor’s Degree or equivalent. Higher degree preferred.

• 6-8 years of experience for Sr. Manager/Minimum 8 years of experience for A.D.
• Profound knowledge in the clinical study management space
• 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