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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Senior Clinical Project Manager - FSP

Job ID 75334BR USA - Any Region - Home Based
About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.



The Clinical Project Manager is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. The position coordinates other functional groups that comprise the clinical department indication team for the product; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects.
  • Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s).
  • Drives all aspects of the project management process from initiation, planning, execution, control and closure. Manages all aspects proactively.
  • Assists in developing protocol concept sheet (study design, entry criteria and schedule of activities table). Reviews protocol and CRFs and tracks development to completion.
  • Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget.
  • Responsible for creating and maintaining MS Project timelines for each project and uses these timelines to track and manage a project’s progress.
  • Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) and Study Data Sheet for each project.
  • Reviews and approves the site contract template and budget template. Will review and approve any variations to the template.
  • Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process).
  • Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management).
  • Ensures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report). Informs all groups of deliverables and timeline, project developments and insures completion according to timelines.
  • Manages and coordinates all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the Request for Proposal processes and overall budget for each.

Qualifications

  • BA/BS or equivalent experience with pharmaceutical/biotech clinical development experience
  • Expertise with MS Project and Excel; Project Management Certification (PMP) is suggested
  • Demonstrated ability to manage and coordinate senior level scientific management personnel and to resolve project issues across organizations.
#INHTF

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.



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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