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Development Feasibility Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    
  • Clinical trial management experience
  • Operational performance experience
  • Project planning experience

Day to Day Responsibilities:    
  • Develop and maintain knowledge of external local clinical trial environment and assess impact on study design and execution
  • Develop and maintain repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
  • Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas
  • Understand patient flows and referral pathways in support of global/local operational delivery
  • Partner with OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
  • Select the sites (support selection for sites in Early Development studies) within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process.
  • Identify and contract Reference Sites in support of local landscaping
  • Engage with local reference sites in collaboration with local medical team to obtain input on proposed study design (Study Design Optimization) and partner with OFSMs and GCPM representatives to analyse local feedback for incorporation into study design and operational planning decisions
  • Support operating reviews by analysing COLA participation and outcomes, predictability and delivery
  • Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification
  • Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager Forum
  • Act, on request, as DFM – POC, coordinating and analysing the COLA outputs and sharing these with GCPM

Responsibilities

Management of indication and study operational landscaping at a country level. Inform stakeholders on country capability. Provide local input into study risk identification and mitigation. Drive Targeted local feasibility. Set up local country commitments and timelines. Develop Country Operational Plan. Drive Voice of Patient and Voice of Site data collection, as applicable. Drive local patient recruitment and retention strategies. Take on DFM POC role to coordinate and support COLA execution and analysis across the countries. Management of indication and study operational landscaping at a country level. Inform stakeholders on country capability. Provide local input into study risk identification and mitigation. Drive Targeted local feasibility. Set up local country commitments and timelines. Develop Country Operational Plan. Drive Voice of Patient and Voice of Site data collection, as applicable. Drive local patient recruitment and retention strategies. Take on DFM POC role to coordinate and support COLA execution and analysis across the countries.

Basic Qualifications
  • BA/BS/BSc or qualified nurse (RN)
  • Experience of 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
  • BA/BS/BSc in life sciences 5 Pharma or biotech
  • Masters Degree, M.D., PharmD 3/1
  • 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 experience
  • International collaboration experience
  • Knowledge
  • Knowledge of local country and international clinical trial management (including regulations & guidelines)

"This posting is for Contingent Worker, not an FTE"

 

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