Priya Mukherjee at CK Clinical is actively seeking an ePRO Manager to work for a leading Pharmaceutical organisation in the South-East.
This ePRO Manager position is primarily responsible for leading the development of ePRO systems to meet the needs of the study/program and internal stakeholders. The incumbent will be required to demonstrate strong project management skills. Technical expertise in ePRO system development, user acceptance testing and provide subject matter expertise to a cross functional study team throughout the lifecycle of the system if preferable. The incumbent will lead all ePRO related activities and will be the point of contact for the supplier and 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.
- Advise/recommend to study teams the supplier and system design alternatives.
- Provide Requests for Proposal documentation, and recommend appropriate vendors to support study needs.
- Provide leadership and subject matter expertise for the completion of supplier set-up activities through lifecycle of the ePRO system.
- Lead the cross functional study team through changes of scope for ePRO, 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
- Serve as the point of contact for inspection readiness activities between the study team and the ePRO supplier.
- Effectively manage internal and external business partner relationships in support of Global Development 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 ePRO system.
- Provide leadership for vendor 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.
The successful applicant for this Contract ePRO Manager role will hold a Bachelor’s degree (or equivalent) in a Scientific/Mathematic or Computer Sciences discipline. They will also have:
- Proven operational experience in clinical trials with a pharmaceutical company and/or a CRO together with demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning.
- Experience with ePRO systems development and ePRO suppliers, together with excellent independent problem solving skill.
For more information or to apply for this Contract ePRO Manager role please contact Priya Mukherjee on 01438 743 047 or email firstname.lastname@example.org. Please quote reference CL24465 in all correspondence.
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