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.
- 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.
- 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
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