Remote Regional Project Lead (Clinical Trials)
PSI CRO AG
πRemote - India
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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 yearsβ site monitoring experience in India
- At least 2 yearsβ 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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