Senior Project Manager

Há 11 horas

Brasil beBeeClinical Tempo inteiro US$100.000 - US$140.000

The Clinical Operations Director is responsible for overseeing the clinical operations of a project at a regional or global level. This includes managing project deliverables, clinical research associates (CRAs), and investigator sites in accordance with the monitoring plan, protocol, good clinical practice (GCP), and local regulations.

Project Oversight
  • Overall oversight of CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
  • Monitoring support visits to aid the site/CRA in satisfactory performance and compliance with standards.
  • Support the clinical project team by providing oversight of study deliverables related to other departments.
  • Oversee regional startup and feasibility activities.
  • Assist in vendor management activities as required per project.
  • Review visit reports for quality, compliance, and appropriate site management.
  • Ensure compliance with high-quality and timely project deliverables according to project requirements and the monitoring plan.
  • Proactively manage site and country performance and inform the clinical project team on progress.
  • Contribute to financial project management processes as applicable.
Project Liaison
  • Conduct regular global CRA calls with the monitoring and site management team.
  • Attend meetings with stakeholders 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.
  • First point of contact for regional CRAs for study-specific questions and issues.
  • Support line managers by providing status updates on utilization and performance of CRAs.
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
  • College diploma/degree and 7-9 years of related experience, plus continuous training and knowledge/skills upgrading.
  • OR undergraduate university degree (Bachelors or Honors Bachelors) and 4-6 years' experience, plus substantial ongoing job-related training.
Other Requirements
  • Health Sciences, Life Sciences, or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
  • Strong experience with EDC systems, proficiency in MS Office, strong written and verbal communication skills, and 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.

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