Operations Project Manager
CurrentThe main purpose of this role is to manage the assigned IVRS global clinical studies and programs in a way that ensures all patients get the right study drug on time and the study and data integrity are maintained from study go live to close out.• Develop the relationship with the client (clinical research manager, drug supply manager, CRAs, biostatisticians, etc) while the study is ongoing • Project management of multiple Clinical Trial Interactive Response Technology (IRT) studies… Show more The main purpose of this role is to manage the assigned IVRS global clinical studies and programs in a way that ensures all patients get the right study drug on time and the study and data integrity are maintained from study go live to close out.• Develop the relationship with the client (clinical research manager, drug supply manager, CRAs, biostatisticians, etc) while the study is ongoing • Project management of multiple Clinical Trial Interactive Response Technology (IRT) studies, Change Orders (COs) as required in various indications including oncology, neurology/ophthalmology and general medicine • Provide regular updates to client on clinical study related information• Proactively review drug supply strategy for improvements and identify risks and focus on resolution• Periodically review clinical study data to identify trends or issues• Provide peer-level training, mentoring of new hires and Jr. PM Staff, and give formal technical training sessions.• Participate in Investigator meetings, bid defences, quarterly business reviews with clients; and support both client and qualification audits• Review Protocols and participate in meetings gathering the requirements for the preparation of IRT and EDC specifications• Coordinate internally with Solutions Designers, programming, validation, integration, release teams to ensure the completion of the IRT project build• Creates and manages an overall project plan, managing and maintaining project timelines• Serve as primary project contact with client to ensure communication is maintained and reporting schedules are adhered• Review test scenarios/Test scripts for IVRS/IWRS/EDC• Perform Smoke tests of the changes before submitting to the client for their testing's• Maintaining the client relationship and liaising with clients at all levels of the study design, build and maintenance phases including the UAT process.• Managing the project amendment process. Show less