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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel 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 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
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV 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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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.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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