Clinical Project Manager

Há 2 dias

Brasil beBeeClinical Tempo inteiro US$90.000 - US$120.000

Clinical Operations Leadership Role Description:

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  • ">
  • The ideal candidate will oversee the clinical operations of a project within a defined regional/global level, ensuring site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.">
">Key Responsibilities:">
  • ">
  • Provide overall oversight of regional Clinical Research Associates (CRAs) to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.">
  • Conduct monitoring support visits (co-monitoring) to aid the site/CRA in satisfactory performance and compliance with standards.">
  • Support clinical project team by providing oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations, etc.).">
  • Oversee regional startup and feasibility activities.">
  • Assist in vendor management activities as required per project.">
  • Perform review of visit reports for quality, compliance, and appropriate site management.">
">Project Liaison">
  • ">
  • Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls.">
  • Attend meetings with Study Sponsor to provide status updates on country and site progress.">
  • Provide operational support and guidance to the monitoring team throughout the project.">
  • Provide project training/mentoring to regional CRAs on study procedures, clinical plans, and guidelines, and timelines for the study.">
">Study Documents and Plans">
  • ">
  • Develop training materials and study tools for sites and CRAs, including monitoring plans.">
  • Develop and implement enrollment and recruitment strategies together with the clinical project team.">
">Qualifications and Requirements">
  • ">
  • Health Sciences, Life Sciences, or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.">
  • Minimum 3 years CRA experience, strong experience with EDC systems, proficient with MS Office, strong written and verbal communication skills, highly effective interpersonal and organizational skills.">
  • Demonstrate proactive, detail-oriented, task-driven, and highly organized attributes.">
  • Critical understanding of GCPs and local regulations as they relate to clinical monitoring, IRB/EC, and Investigator responsibilities.">
  • Strong ability to critically understand clinical research documents and report writing.">
">

This role requires strong leadership, organizational, and communication skills. The ideal candidate will have experience in clinical operations and be able to work effectively in a dynamic environment.

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