Clinical Regional Project Lead

🔥 43 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 project team activities in designated countries and ensure consistency of Clinical Operations processes across regions • 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 when delegated by the Project Manager • Collect and report project status updates for designated regions internally and externally • Develop and update project planning documents, essential study documents, and project manuals/instructions • Manage and report KPIs for designated countries and clinical project team members • Ensure project timelines and subject enrollment targets are met • Coordinate study-specific and corporate tracking systems • Coordinate site contractual startup and budget negotiations • Establish project-team communication lines and supervise clinical project team members’ performance • Identify, escalate, and resolve resourcing and performance issues • Conduct or supervise therapeutic-area training and prepare Investigator presentations • Ensure compliance with project-specific training matrices • Perform field training of Monitors tailored to project needs • Supervise site selection, site initiation, routine monitoring, and closeout visits • Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution • Supervise preparation for study audits/inspections and resolution of findings • Coordinate supervised monitoring visits and review site visit reports • Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications • Oversee safety information flow and participate in feasibility research • Review and approve project-related expenses and timesheets when delegated by the Project Manager

🎯 Requirements

• College/University degree in Life Sciences or equivalent combination of education, training, and experience • Prior experience in Clinical Research and on-site monitoring • 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 • Experience in Oncology • 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 • Career advancement opportunities • Hands-on involvement in every aspect of clinical studies • Opportunity to lead challenging full-service projects • Work with a company that puts its people first