Regional Project Lead

🕒 4 days 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

• Plan, implement, and manage clinical research 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 report progress 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 in designated countries • 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 of project teams when delegated • Prepare presentations and conduct Investigator training • Ensure team compliance with project-specific training matrices • Conduct 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 project-team preparation for study audits/inspections and resolution of findings • Coordinate supervised monitoring visits • Review site visit reports and ensure monitoring and 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 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 required • Prior experience in Clinical Research and independent on-site monitoring required • Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent required • Therapeutic expertise in Oncology and/or Gastroenterology required • 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 • Must not require a work visa for employment or continued employment now or anytime in the future

🏖️ Benefits

• Flexible working arrangements • Career growth and professional development • Opportunities to lead complex global studies • Collaborative, people-first culture • Stable organization where long-term careers are built • Meaningful work that helps bring innovative therapies to patients around the world