Опубликовано: 08 Сен 2021
Value Evidence Outcomes &Key Evidence Generation Manager
Due to number of evidence generation projects led by different functions within LOC it’s clear unmet need to introduce a new role of Value Evidence Outcomes &Key Evidence Generation Manager to coordinate, manage and oversee of Evidence generation activities in relevant TA/TAs in Russia.
The role of Value Evidence Outcomes &Key Evidence Generation Manager (VEO&KEG Manager) is essential to plan, oversight execute LOC KEG projects with external contractors and suppliers to ensure delivery on time, to budget and in accordance with user specifications. Ensure optimal planning and management of studies resources (budget and people) including relevant data dissemination activities.
• Accountable for delivery of assigned KEG studies to time, budget and quality expectations as defined in Integrated Evidence Plan and country-specific Medical Plan for relevant TA/TAs in accordance with local regulations, IND/GCP/ICH/GEP guidelines, GSK Corporate and local SOPs and POLs.
• Leads cross-functional experts (medical, market access, finance, legal, etc.) and Vendor staff involved in study preparation and delivery; providing both matrix leadership and project management of local KEG study activities.
• Ensures that critical study timelines are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Ensures efficient study delivery by Vendors (CROs).
• Manage contract development with CROs /Vendors and lead budget/contract negotiations with study vendors including vendors technical qualifications assessment.
• As required, involved in study protocol and local Informed Consent Form development for the relevant study.
• Accountable for reporting study delivery progress to VEO&KEG Head and key stakeholders.
• Identifies and resolves in collaboration with CRO or escalate risks and issues that may impact study delivery to VEO&KEG Head Russia.
• As required, act as Publication Accountable Person and manage and deliver study related publications including Health Economics Models publications.
• Support external stakeholder engagement Medical Affairs strategy on generated data dissemination activities.
• Report and work under the direction with VEO&KEG Head Russia to ensure robust high-quality TA KEG study plans and delivery.
• Develop and deliver in collaboration with VEO&KEG Head Russia and cross functional teams EG / Value Access capability building plan & implement appropriate training programs.
• Acquires and maintains an appropriate level of knowledge on relevant TA/TAs studied, competitive landscape, local treatment guidelines and local health care system requirements.
• Continuously develops knowledge in the areas of GCP&GEP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Responsible to identify and share best practices.
• Higher education in pharmacy / biology / chemistry; PhD – desirable;
• Specialization in health economics, health outcomes research, clinical trials, epidemiology, internal diseases or equivalent combination.
• Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
• Strategic and technical expertise in market access and evidence generation strategy development & implementation
• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
• Ability to work with different stakeholders across the business
• Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
• Good understanding of product development and launch processes
• Strong written and verbal communications skills are required in English
What we can offer:
• Competitive salary;
• Medical insurance, life insurance;
• Meal allowance;
• Mobile compensation;
• Internal and external educational courses and trainings;
• Professional and career development opportunities (locally as well as worldwide).