PSI CRO AG is a distinguished Contract Research Organization (CRO) with over 25 years of expertise in the pharmaceutical industry. Originating in Switzerland, PSI is known for its high-quality, full-service support for global clinical trials across diverse therapeutic areas. With a strong commitment to stability and minimal staff turnover, PSI prioritizes building an inclusive and supportive work environment for its team members.

Role Summary:
The Lead Clinical Research Associate (Lead CRA) will be responsible for overseeing study startup, site monitoring, and clinical site management for global research projects. This role includes acting as the primary communication link between sponsors, project managers, and clinical sites, while ensuring compliance with protocol, regulatory guidelines, and internal standards.

Key Responsibilities:

• Project Oversight: Monitor project timelines and patient recruitment; implement corrective and preventive measures as needed.
• Communication: Serve as the main point of contact for protocol updates and site communications.
• Site Monitoring: Conduct site visits and manage site activities.
• Feasibility and Start-up Coordination: Oversee the investigator/site feasibility process and manage study startup activities.
• Regulatory Review: Review and approve regulatory packages and site documentation.
• CRA Supervision: Oversee and support CRAs, including reviewing monitoring reports and aiding in query resolution.
• Training and Support: Prepare training materials, conduct project-specific training sessions, and lead investigator meetings.
• Site Audit Preparation: Conduct site audit visits and support audit resolution processes.
• Clinical Supplies: Manage supply chain processes in collaboration with vendors.
• Team Management: Lead project teams, manage site contracts and payments, and facilitate project team calls at the country level.
• Documentation: Ensure timely updates to project-specific and corporate tracking systems.

Qualifications:

• Education: Degree in Life Sciences, Pharmacy, RN, or an equivalent mix of education, training, and experience.
• Experience:
  • Proven track record as a Lead or Senior CRA in clinical projects.
  • Independent monitoring experience in India.
• Skills:
  • Full working proficiency in English.
  • Proficiency in MS Word, Excel, and PowerPoint.
  • Strong planning, multitasking, and dynamic teamwork capabilities.
  • Excellent communication, leadership, and problem-solving skills.
• Travel: Ability to travel as required for site visits and project needs.