PSI CRO AG is hiring a
Regional Project Lead

Summary

Join PSI as Regional Project Lead and manage project teams in designated countries, ensuring consistency of Clinical Operations processes across regions.

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 4 years of experience in Clinical Research and site monitoring activities
• At least 2 years of expereince as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent
• Experience in Oncology 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

Responsibilities

• Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
• Acts as primary or secondary project management contact for the project team and PSI support services in designated countries
• Performs study status review and progress reporting (if delegated by the Project Manager)
• Collects and reports project status updates for designated regions, both internally and externally
• Develops and updates project planning documents, essential study documents and project manuals/ instructions
• Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members
• Ensures that the project timelines and subject enrollment targets are met in designated countries
• Coordinates maintenance of study-specific and corporate tracking systems
• Coordinates site contractual startup and budget negotiations
• Establishes communication lines within the project team and supervises clinical project team members’ performance
• Identifies, escalates and resolves resourcing and performance issues
• Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
• Prepares presentations and conducts training of Investigators
• Ensures team compliance with project-specific training matrix
• Performs field training of Monitors tailored to the project needs
• Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
• Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
• Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
• Coordinates conduct of supervised monitoring visits
• Reviews site visit reports and ensures monitoring and reporting standards are met
• Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
• Oversees the safety information flow and participates in feasibility research
• Reviews/ approves project related expenses and timesheets (if delegated by the Project Manager)