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Global Feasibility Senior Manager
2 weeks ago
The Senior (Snr) Manager, Feasibility, will support early evaluations for proposed new studies originating within the Sponsor.nThe 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.nThe Senior Manager, Feasibility, will support the implementation of new technology, processes, and applications to assist in the development of the sponsor's viability capability.nThe Senior Manager, Feasibility, will support the implementation of new technology, processes, and applications to assist in the development of the sponsor's viability capability.nThe Senior Manager Director, Feasibility may be involved in recruitment to build the team's capability.
Essential Functions
Ability to evaluate the intent of the study concept and make informed recommendations based on scientific review and information available at the time of the requestnAbility 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.nUtilize tools (e.g. Medidata, Symphony (Real World Evidence)) to generate data specific to satisfy feasibility/viability requests.nAuthoring 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.nCross-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 studynAuthor 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.nAbility to author scientific documentation to support viability consideration.nUtilization of software applications to support data collection and precise interpretation of this data to assist in evaluating the study viability.
Required/Preferred Education
Extensive pharmaceutical or related industry experience, minimum 8-10 years industry experience.nExcellent knowledge of GCP and regulationsnExperience of team management
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