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FSP - Associate Clinical Trial Manager

Job ID 75331BR 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 Summary
The 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.

Principal 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.
  • Create and maintain clinical trial documents.
  • Participate in the identification, evaluation, and selection of clinical trial sites.
  • Conduct data review.
  • Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging.
  • Support CTMS and Trial Master File completeness.
  • Support audit and/or inspection activities
  • May manage CRO activities.
  • Support Clinical Trial Manager(s). Collaborates with internal team members, Contract Research Organizations, vendors and sites.
  • Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
  • May contribute to process improvement initiatives and departmental projects.

Qualifications

Required Qualifications
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial management experience.
  • Ability and willingness to travel
  • Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
  • Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
  • Strong communication and inter-personal skills.
  • Highly responsive and proactive, a team player
  • Knowledge of CFR and GCP/ICH requirements
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
Preferred Qualifications
  • Global Clinical Trial Management experience.
  • Oncology clinical research experience.
  • 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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