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- Bachelor's degree
- 6+ years of operational experience in clinical trials with a pharmaceutical company, clinical research organization, and/or clinical technology company
- Strong project management skills and presentation skills, including the ability to lead a team independently
- Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning
- Familiarity with industry best practices for vendor management
- Advanced degree
- Experience working with IVRS/IWRS suppliers
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
- Lead the development of IVR/IWR/IRT systems to meet the needs of the study / program and internal stakeholders.
- Demonstrate technical expertise in IVR/IWR system development and user acceptance testing (UAT)
- Provide subject matter expertise to a cross-functional study team throughout the life cycle of the system.
- Lead all IVR/IWRS/IRT related activities and serve as point of contact for the cross-functional study team.
- Provide advice/recommendations to study teams regarding supplier and system design alternatives
- Provide request for proposal documentation, recommend appropriate suppliers to support study needs
- Provide leadership and subject matter expertise for the completion of supplier set-up activities through the lifecycle of the system
- Lead the study team by providing technical expertise on the change of scope, assessment of risk, oversight of system requirements / updates, and UAT
- Lead the resolution of issues escalated by study teams as well as specific cross-team issues, as applicable
- Demonstrate sufficient knowledge of randomization and medication assignment processes to be able to perform required unblinded assessments of the IVR/IWR/IRT system performance (or functionality)
- Serve as the point of contact for inspection-readiness activities between the study team and the IVRS/IWRS/IRT supplier
- Manage internal and external business partner relationships in support of R&D Operations' deliverables
- Monitor KPIs for services provided by external service providers
- Conduct Lessons Learned sessions following the completion of study start-up activities and (as needed) throughout other phases of the clinical development process
- Support the study team in close-out/deactivation of the IVR/IWR/IRT system
- Continually assess new emerging technologies to optimize operational efficiencies