Regional Project Lead

🕒 August 7

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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

• Streamline activities of project teams and ensure consistency of Clinical Operations processes across North America • Ensure study milestones are met by project teams at country level • Report study progress to clients and global stakeholders • Act as project management contact for project teams and PSI support services • Review study status and progress; collect and report project status updates • Develop and update project planning documents, essential study documents, and project manuals/instructions • Ensure project timelines and subject enrollment targets are met • Coordinate study-specific and corporate tracking systems • Oversee site selection and startup, contractual negotiations, and budget negotiations • Supervise project team and site training; perform field training of monitors • Ensure compliance with project-specific training matrices • Supervise site selection, initiation, monitoring, and closeout visits • Review site visit reports and ensure monitoring and reporting standards are met • Oversee investigator and site payments • Supervise preparation for study audits/inspections and resolution of findings • Participate in regional project oversight for North America

🎯 Requirements

• MPharm, RN, or university/college degree in Life Sciences, or equivalent combination of education, training, and experience • Minimum 4 years of site monitoring experience • At least 2 years of experience as Lead Monitor • Experience supervising clinical project activities and leading clinical project teams • Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications preferred • 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

🏖️ Benefits

• Stable and secure workplace • Inclusive culture • Professional development and success investment • Remote work option