Clinical Regional Project Lead

🔥 14 minutes ago

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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

• Oversee, manage, and coordinate clinical trial project-team activities in designated countries and ensure consistency of Clinical Operations processes across regions • Ensure study milestones, timelines, and subject-enrollment targets are met at country and regional levels • Plan, implement, and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents • Act as primary or secondary project-management contact for project teams and PSI support services in designated countries • Review study status and provide progress reporting • Collect and report project-status updates internally and externally • Develop and update project-planning documents, essential study documents, and project manuals/instructions • Manage and report Key Performance Indicators for designated countries and clinical project-team members • Coordinate study-specific and corporate tracking systems • Coordinate site contractual startup and budget negotiations • Establish project-team communication lines and supervise clinical project-team performance • Identify, escalate, and resolve resourcing and performance issues • Conduct or supervise therapeutic-area training and Investigator training • Ensure compliance with project-specific training matrices • Provide field training to Monitors • Supervise site selection, site initiation, routine monitoring, and closeout visits • Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution • Supervise project-team preparation for audits/inspections and resolution of findings • Coordinate supervised monitoring visits • Review site visit reports and ensure monitoring/reporting standards are met • Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications • Oversee safety-information flow and participate in feasibility research • Review/approve project-related expenses and timesheets when delegated by the Project Manager

🎯 Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required • Prior experience in Clinical Research and on-site monitoring is required • Prior experience monitoring within the US • Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent is required • Experience in Oncology is required • Experience in GI is preferred • Full working proficiency in English • Proficiency in MS Office applications, including MS Project • Communication, presentation, and customer-service skills • Ability to negotiate and build relationships at all levels • Team-building, leadership, and organizational skills

🏖️ Benefits

• Remote work option • Hands-on involvement in every aspect of the study • Career growth opportunities • Work with a company that puts its people first