Clinical Regional Project Lead

🔥 20 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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

• Oversee, manage, and coordinate activities of project teams in designated countries • Ensure consistency of Clinical Operations processes across regions • Ensure study milestones 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 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 Key Performance Indicators for designated countries and clinical project team members • Ensure 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 project-team communication lines and supervise clinical project team performance • Identify, escalate, and resolve resourcing and performance issues • Conduct and supervise therapeutic-area training of the project team when delegated • Prepare presentations and conduct Investigator training • Ensure team compliance with the project-specific training matrix • 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 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 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 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 • Communication, presentation and customer-service skills • Ability to negotiate and build relationships at all levels • Team building, leadership and organizational skills

🏖️ Benefits

• Employees can work remotely • Opportunity to advance career in clinical research • Learning new things while growing with a rapidly growing company that puts its people first