Regional Project Lead

🕒 August 10

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 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 • Develop and update project planning documents, essential study documents, project manuals, and 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 team-member performance • Identify, escalate, and resolve resourcing and performance issues • Conduct or supervise therapeutic-area training • Prepare presentations and conduct Investigator training • Ensure compliance with the project-specific training matrix • Conduct field training of 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 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 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

🎯 Requirements

• College/University degree in Life Sciences or equivalent combination of education, training, and experience • Prior experience in Clinical Research and independent on-site monitoring • Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent • Therapeutic expertise in Oncology and/or Gastroenterology • 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 in the future

🏖️ Benefits

• Flexible working arrangements • Career growth and professional development • Collaborative, people-first culture • Stable organization with long-term career opportunities • Meaningful work helping bring innovative therapies to patients around the world