Regional Project Lead

🕒 July 17

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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 activities of project teams in designated countries • Ensure consistency of Clinical Operations processes across regions • Ensure meeting study milestones are met by the project team on a country and regional level • Ensure planning, implementation, and management of projects in compliance with industry regulations • Act as primary or secondary project management contact for the project team and PSI support services in designated countries • Perform study status review and progress reporting • Collect and report project status updates for designated regions • Develop and update project planning documents, essential study documents and project manuals/instructions • Manage and report on Key Performance Indicators (KPIs) for designated countries and clinical project team members • Ensure that the project timelines and subject enrollment targets are met • Coordinate maintenance of study-specific and corporate tracking systems • Coordinate site contractual startup and budget negotiations • Establish communication lines within the project team and supervise clinical project team members’ performance • Identify, escalate and resolve resourcing and performance issues • Conduct and supervise therapeutic area training of the project team • Prepare presentations and conduct training of Investigators • Ensure team compliance with project-specific training matrix • Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits • Oversee investigator and site payments, as well as CRF data retrieval/upload and monitoring and the query resolution process • Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings • Coordinate conduct of supervised monitoring visits • Review site visit reports and ensure monitoring and reporting standards are met • Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications • Oversee the safety information flow and participate in feasibility research • Review/approve project related expenses and timesheets

🎯 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 • Experience as a Study Manager/Clinical Trial Manager with the 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

🏖️ Benefits

• Health insurance • Professional development opportunities