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Global Feasibility Senior Manager
4 months ago
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 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 request
- Ability 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 study
- Author 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 Education
- Extensive pharmaceutical or related industry experience, minimum 8-10 years industry experience.
- Excellent knowledge of GCP and regulations
- Experience of team management
