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Associate Clinical Trial Manager - FSP

Job ID 79992BR 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.

Position Purpose:
This Associate Clinical Trial Manager is the Regional Clinical Trial Operations (RCTO) individual
responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones. May act in support or lead role.

Primary Responsibilities:
  • May act as study lead and participate on the cross-functional study team.
  • May act as mentor for less senior RCTO staff on the study.
  • Creates and maintains clinical trial documents.
  • Participates in the identification, evaluation, and selection of clinical trial sites.
  • Conducts data review.
  • Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging.
  • Supports Clinical Trial Master System (CTMS) and Trial Master File (TMF) completeness.
  • Supports audit and/or inspection activities.
  • May manage Contract Research Organization (CRO) activities.
  • Supports Clinical Trial Manager(s). Collaborates with internal team members, CROs, vendors and sites.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Performs all duties and responsibilities in accordance with Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines, SOPs, and other applicable guidelines.
  • May contribute to process improvement initiatives and departmental projects.
  • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.



Education and Certification:
  • Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
Skills and Experience:
  • Minimum of 5 years of relevant clinical trial management experience.
  • Oncology clinical research experience is preferred.
  • Global Clinical Trial Management experience is preferred.
  • Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
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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