Senior Manager, Feasibility

7 days ago


Oklahoma City, United States Oklahoma Staffing Full time

Senior Manager, FeasibilityParexel FSP has an exciting opportunity 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 activitiesAbility 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 as required to ensure viability output fulfills the team's requirements.Utilization of tools (e.g. Medidata, Symphony (Real World Evidence)) to generate data specific to satisfy feasibility/viability requestsAuthoring 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 studyAuthor review/verification to support the feasibility/viability team to meet timeline delivery for requestsCollaborative 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 compliance with Parexel standardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills:Ability to author scientific documentation to support viability considerationUtilization of software applications to support data collection and clear interpretation of this data to assist in the evaluation of the study viabilityKnowledge and Experience:Scientific understanding for the areas of interest for the client to help support effective viability considerationsExcellent knowledge of GCP and regulationsExperience of team managementExtensive pharmaceutical or related industry experienceMinimum 5 years of relevant experienceEducation:Bachelor's degree (or equivalent), Master's degree or health data sciences degree preferred.EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.



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