HireDiversity

Raritan, NJ, US

External Partnerships Manager (IVR/IWR)-000009ND

Description

Janssen Research & Development LLC., a member of the J&J family of companies, is actively seeking a External Partnerships Manager (IVR/IWR), located in Raritan, NJ, Titusville, NJ, or Malvern, PA OR High Wycombe, England OR Beerse, Belgium.

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Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

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 Global Operations Services 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, External Partnerships

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 GDO 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.

Provide leadership for supplier assessment/qualification teams

Continually assess new emerging technologies to optimize operational efficiencies.

Represent Global Operations Services as an External Partnerships 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

Qualifications


Bachelor's degree (University degree) or equivalent education required; advanced degree preferred. At least 5 years operational experience in clinical trials with a pharmaceutical company and/or a CRO 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 J&J is involved is preferred. Experience with IVRS/IWRS suppliers is preferred.

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

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:Europe/Middle East/Africa-United Kingdom-England-Buckinghamshire, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Coordination