Job Description

Company DescriptionPSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.In this role you will streamline activities of project teams in India and ensure consistency of Clinical Operations processes across the region. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.Home-based in MumbaiThe scope of responsibilities will include:

• 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

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

Additional InformationMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

PSI CRO