The Senior Manager, Feasibility will support early evaluations for proposed new studies and undertake evaluations to determine whether a study proposal is viable utilizing in house knowledge, technology capability and other resources as able to provide a scientific based rational for inclusion of countries, sites and potential investigators in new study development. Additionally, this role will support implementation of new technology, processes, and applications to assist in the development of the viability capability within the program and may be involved in recruitment to build the team's capability.
Key Accountabilities :
Oversight of activities - 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 as required to ensure viability output fulfills the teamsteam's requirements.
- Utilization of tools (e.g. Medidata, Symphony (Real World Evidence)) to generate data specific to satisfy feasibility/viability requests
- Authoring of reports to inform project teams of assessment, to include such data as enrolment 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 selection of best countries/ sites to ensure the necessary patient populations are available to aid recruitment for the study
- Author review/verification to support the feasibility/viability team to meet timeline delivery for requests
Collaborative relationships - Collaborates effectively with cross-functional teams to evaluate study concepts, generate data-driven insights, and deliver comprehensive feasibility reports that align with project requirements and optimize site and country selection for successful clinical trial execution.
Compliance with Parexel standards - Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills: - Ability to author scientific documentation to support viability consideration.
- Utilization of software applications to support data collection and clear interpretation of this data to assist in the evaluation of the study viability.
Knowledge and Experience :
- Scientific understanding for the areas of interest for the client to help support effective viability considerations
- Excellent knowledge of GCP and regulations
- Experience of team management
- Extensive pharmaceutical or related industry experience,
- Minimum 5 years of relevant experience.
Education: - Bachelor's degree (or equivalent), Master's degree or health data sciences degree preferred.
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