Posted to MedZilla on 7/30/2017

TechData Services




This position is primarily responsible for leading the development of IVR/IWR systems to meet the needs of the study/program and internal stakeholders. The incumbent will be required to demonstrate technical expertise in IVR/IWR system development, user acceptance testing and provide subject matter expertise to a cross functional study team throughout the lifecycle of the system. The incumbent will lead all IVRS/IWRS related activities and will be the point of contact for the cross-functional study team. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure RTSM processes are at the ‘best practice’ level of performance. 

Job Responsibilities: 

• Provide Advice/recommendation to study teams regarding the supplier and system design alternatives 
• Provide Requests for Proposal documentation, and recommend appropriate suppliers to support study needs 
• Provide leadership and subject matter expertise for the completion of supplier set-up activities through lifecycle of the IVR/IWR system 
• Lead the cross functional study team through changes of scope for IVRS/IWRS, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates and user acceptance testing 
• Lead the resolution of issues escalated by study teams as well as cross-team specific issues under the supervision of the Director or Associate Director, RTSM as applicable 
• Demonstrate sufficient knowledge of randomization and medication assignment processes to be able to perform required un-blinded assessments of the IVR/IWR system performance (or functionality) should that be assigned 
• Serve as the point of contact specific to inspection readiness activities between the study team and the IVRS/IWRS supplier 
• Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables 
• Monitor key performance indicators for services provided by external service providers 
• Conduct Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process 
• Effectively support the study team in close-out/deactivation of the IVR/IWR system 
• Continually assess new emerging technologies to optimize operational efficiencies 
• Represent PDMS as an IVR/IWR expert at cross-company meetings and at external professional meetings 
• Ensure that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships 


• Bachelor’s degree (University degree) or equivalent education required; advanced degree preferred 
• At least 6 years operational experience in clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required 
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required 
• Familiarity with industry best practices for vendor management is required 
• Good understanding of the therapeutic areas where Janssen is involved is required 
• Experience with IVRS/IWRS suppliers is preferred 
• Strong project management skills and presentation skills with the ability to lead a team independently 

This is a manager level position where independent problem solving and attention to detail is expected and required.

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