Remote Regional Project Lead (Clinical Trials)

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PSI CRO AG

πŸ“Remote - India

Job highlights

Summary

Join the company that focuses on its people and invests in their professional development and success, as a Clinical Project Manager in India.

Requirements

  • MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience
  • Minimum 4 years’ site monitoring experience in India
  • At least 2 years’ experience as Lead Monitor
  • Experience supervising clinical project activities and leading clinical project teams
  • Experience in oncology, gastroenterology, infectious diseases, or rare disease indications is preferable
  • Communication, presentation, and customer-service skills
  • Team building, leadership and organizational skills
  • Full working proficiency in English
  • Proficiency in MS Office applications, including MS Project

Responsibilities

  • Coordinate clinical project teamwork
  • Act as project management contact for the project team and PSI support services
  • Act as a contact for global clients, contractors, subcontractors and third-party vendors
  • Perform study status review and progress reporting, collect and report project status updates
  • Develop and update project planning documents, essential study documents and project manuals/ instructions
  • Supervise clinical project team performance, manage, and report on Key Performance Indicators (KPIs)
  • Ensure that the project timelines and subject enrollment targets are met
  • Coordinate maintenance of study-specific and corporate tracking systems
  • Oversee site selection and startup, site contractual and budget negotiations
  • Supervise project team and site training, perform field training of monitors tailored to the project needs
  • Ensure team compliance with project-specific training matrix
  • Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
  • Review site visit reports and ensures monitoring and reporting standards are met
  • Oversee investigator and site payments
  • Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings

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