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Global Feasibility Senior Manager

Posted 5 days ago

  • London, Greater London
  • Any
  • External
  • Expires In 3 months
Advanced Clinical is seeking a Global Senior Manager in Feasibility to work for a European-based Global Biotech specializing in Oncology.The Senior (Snr) Manager, Feasibility, will support early evaluations for proposed new studies originating within the Sponsor.The Senior Manager, Feasibility, will undertake evaluations to determine whether a study proposal is viable utilising in-house knowledge, technology capability, and other resources. The manager will be able to provide a scientific-based rationale for including countries, sites, and potential investigators in new study development.The Senior Manager, Feasibility, will support the implementation of new technology, processes, and applications to assist in the development of the sponsor's viability capability.The Senior Manager, Feasibility, will support the implementation of new technology, processes, and applications to assist in the development of the sponsor's viability capability.The Senior Manager Director, Feasibility may be involved in recruitment to build the team's capability.Essential FunctionsAbility to evaluate the intent of the study concept and make informed recommendations based on scientific review and information available at the time of the requestAbility to effectively communicate with key stakeholders through this initial viability/ feasibility concept phase, seeking additional information to ensure viability output fulfils the team's requirements.Utilize tools (e.g. Medidata, Symphony (Real World Evidence)) to generate data specific to satisfy feasibility/viability requests.Authoring reports to inform project teams of assessment, including data such as enrollment rates, location of patient populations, local practices, considerations of protocol designs, Site ID, and risks.Cross-functional working (e.g. with real-world evidence team, GPSS, Clinical Monitoring team) to facilitate processes to support therapeutic landscape evaluations to assist in the selection of best countries/ sites to ensure the necessary patient populations are available to aid recruitment for the studyAuthor review/verification is needed to support the feasibility/viability team in meeting timeline delivery for requests.Experience Scientific understanding of the areas of interest for the sponsor to help support compelling viability considerations.Ability to author scientific documentation to support viability consideration.Utilization of software applications to support data collection and precise interpretation of this data to assist in evaluating the study viability.Required/Preferred EducationExtensive pharmaceutical or related industry experience, minimum 8-10 years industry experience.Excellent knowledge of GCP and regulationsExperience of team management
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