Trial Committee Manager

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Manage the full lifecycle of clinical trial committees, from committee setup and member selection through study conduct and close-out • Coordinate committee meetings, communications, recommendations, and follow-up activities throughout clinical trials • Develop, maintain, and update committee charters, procedures, and other trial-specific documentation • Identify, evaluate, and engage qualified external committee members based on study requirements, expertise, availability, and independence criteria • Perform Fair Market Value assessments and prepare honorarium estimates for independent committee members • Support audits and inspections related to committee management activities and contribute to corrective and preventive actions • Contribute to the development and continuous improvement of committee-related quality documentation, business processes, templates, and training materials • Support the planning and delivery of internal training on committee management processes • Coordinate sponsors, committee members, external experts, and cross-functional PSI teams to ensure efficient, compliant, high-quality committee activities

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Healthcare, Clinical Research, or a related field • At least 3 years of experience in clinical research, preferably within a CRO environment • Experience managing or coordinating clinical trial committees, or comparable clinical trial management experience with exposure to committee processes • Proven project management and stakeholder coordination skills • Ability to manage multiple priorities in a fast-paced environment • Strong organizational, communication, and problem-solving skills • Exceptional attention to detail • Ability to build effective working relationships with sponsors, external experts, and cross-functional teams • Professional proficiency in English, written and spoken • Proficiency in Microsoft Office applications and virtual meeting platforms

🏖️ Benefits

• Remote work option / home-based work in Germany • Collaborative, globally connected team • Opportunities to grow, contribute, and make a meaningful impact on global healthcare • Internal training opportunities