Clinical Regional Project Lead

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

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

• Streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. • Ensure meeting study milestones by project teams on a country level. • Report study progress to clients and global stakeholders. • Act as project management contact for the project team and PSI support services. • Perform study status review and progress reporting, collect and report project status updates. • Develop and update project planning documents, essential study documents and project manuals/instructions. • Ensure that the project timelines and subject enrollment targets are met. • Coordinate maintenance of study-specific and corporate tracking systems. • Oversee site selection and startup, site contractual and budget negotiations. • Supervise project team and site training, perform field training of monitors tailored to the project needs. • Ensure team compliance with project-specific training matrix. • Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits. • Review site visit reports and ensures monitoring and reporting standards are met. • Oversee investigator and site payments. • Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings. • Might be involved in regional project oversight for APAC.

🎯 Requirements

• MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience. • Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor, preferably in regional capacity. • Experience supervising clinical project activities and leading clinical project teams. • Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable. • Communication, presentation, and customer-service skills. • Team building, leadership and organizational skills. • Full working proficiency in English. • Proficiency in MS Office applications, including MS Project.

🏖️ Benefits

• Professional development opportunities