Company: DOCS Global
Location: High Wycombe,United Kingdom
Reference: Ref AS-019788
Closing Date: 20 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Exciting opportunity to work for a Top Global Pharma, the TOP 30 companies to work for (As listed on the Sunday Times 2016). Our client is now seeking an experienced Project Manager in ePRO Systems to work within their team as a Clinical Technology Services Manager, ePRO. The role is office based in Buckinghamshire with flexibility of working from home 2 days a week! The role is permanent through DOCS and contracted to our client long term/indefinate.
Roles & Responsibilities of the position
Provide advice/recommendation to study teams regarding the supplier(s) and device/technology alternatives
Complete Requests for Proposal documentation, and recommend appropriate suppliers to support study needs
Provide leadership and expertise for the completion of supplier specification development and set-up activities through lifecycle of the trial
For all protocol-dictated PROs and ClinROs: research copyright & language availability, ensure permission/licensing, obtain required study translations (requires working with
preferred translations vendors) according to the FDA’s PRO Guidance
Lead the cross functional study team through changes of scope for ePRO/pPRO (including ClinROs), 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, Clinical Technology Services
Serve as the point of contact specific to inspection readiness activities between the study team and the ePRO/pPRO supplier (s)
Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables
Monitor key performance indicators (KPIs) for services provided by suppliers
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 supplier assessment/qualification teams
Continually assess new emerging technologies to optimize operational efficiencies
Represent Clinical Technology Services as an ePRO/pPRO subject matter expert at internal cross-company meetings and at external professional meetings
Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier rel
Bachelor’s degree (University degree) or equivalent education required
• 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
• Experience with ePRO/pPRO suppliers is preferred
• Strong project management skills and presentation skills with the ability to lead a team independently
• Base salary
• Car Allowance of £5760 on top of base
• Private BUPA healthcare
• Life Assurance
• Childcare Vouchers
• 25 days Annual leave which extends to 1 day each year to a max of 27 days.
• Permanent employee of DOCS
• Flexibility of Home working 2 days a week. DOCS provides a Smart Phone and client provides you with laptop
**** Please Contact Tanzina Guerni directly on: 01932 269 754 OR email me your CV at: Tanzina.Guerni@docsglobal.com for more information!***
CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Permanent, Clinical Research, Project Management, Senior Project Manager, Manager, ePRO systems, Vendor Management, problem Solving, Presentation, Buckinghamshire, High Wycombe, UAT, User Acceptance Testing.
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