Regional Project Lead

7 days ago


Mumbai, Maharashtra, India PSI CRO Full time
Job Title: Regional Project Lead

PSI CRO is seeking a highly skilled Regional Project Lead to join our team in Mumbai. As a Regional Project Lead, you will be responsible for streamlining project team activities in India and ensuring consistency of Clinical Operations processes across the region.

Key Responsibilities:
  • Coordinate clinical project teamwork to ensure timely completion of project milestones
  • Act as project management contact for the project team and PSI support services
  • Manage global client relationships, contractors, subcontractors, and third-party vendors
  • 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 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 ensure 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
Qualifications:
  • 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
Why Join PSI CRO?

At PSI CRO, we focus on our people and invest in their professional development and success. We offer a dynamic and supportive work environment that allows our employees to grow and thrive. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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