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Development Feasibility Mgr - Brazil  

Company managed [?] Still accepting applications

Posted on : 07 May 2017

Project Description

Key Activities
  • Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with and knowledge of current investigators in alignment with company’s product clinical development plans.
  • Develop repository of local site intelligence information (Country Landscaping) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
  • Identify and contract with Reference Sites in support of local landscaping
  • Understand local outreach and patient referral pathways in support of global/local operational delivery
  • Develop and maintain knowledge of external local clinical trial environment and assess developments for impact on study design and execution (Horizon Scanning)
  • Partner with Global Feasibility Operations Director (GFOD) and Development Design Center (DDC) to provide local country landscaping data for inclusion in the Evidence Generation Plan and study design as applicable
  • Engage with local reference sites to obtain input on proposed study design (Study Design Optimization) as requested by GFOD/DDC and partner with GFOD to analyse local feedback for incorporation into study design and operational planning decisions
  • Support operating reviews by monitoring predictability and delivery, and perform refinements required to local site intelligence data
  • Use site intelligence and local cross-functional input for study-level operational planning in support of validation of country commitment for a study
  • Ensure consistency of activities and development of best practices through leadership / participation in Global Development Feasibility Manager forum



Requirements:
Basic Qualifications
  • BA/BS/BSc or qualified nurse (RN)
  • Work experience working in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred Qualifications
  • Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Clinical trial management experience
  • Operational performance measurement experience
  • International collaboration experience Knowledge
  • Fluent in spoken / written English
  • Knowledge of local country and international clinical trial management (including regulations & guidelines)