PpbJob Description /b /p /ppThe Regional Project Lead is a senior level clinical trial manager who oversees, manages, and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level. /pliEnsures 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) /liliActs as primary or secondary project management contact for the project team and PSI support services in designated countries /liliPerforms study status review and progress reporting (if delegated by the Project Manager) /liliCollects and reports project status updates for designated regions, both internally and externally /liliDevelops and updates project planning documents, essential study documents and project manuals/ instructions /liliManages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members /liliEnsures that the project timelines and subject enrollment targets are met in designated countries /liliCoordinates maintenance of study-specific and corporate tracking systems /liliCoordinates site contractual startup and budget negotiations /liliEstablishes communication lines within the project team and supervises clinical project team members’ performance /liliIdentifies, escalates and resolves resourcing and performance issues /liliConducts and supervises therapeutic area training of the project team (if delegated by the Project Manager) /liliPrepares presentations and conducts training of Investigators /liliEnsures team compliance with project-specific training matrix /liliPerforms field training of Monitors tailored to the project needs /liliSupervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits /liliOversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process /liliSupervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings /liliCoordinates conduct of supervised monitoring visits /liliReviews site visit reports and ensures monitoring and reporting standards are met /liliCoordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications /liliOversees the safety information flow and participates in feasibility research /liliReviews/approves project related expenses and timesheets (if delegated by the Project Manager) /libr/ppbQualifications /b /p /pliCollege/University degree in Life Sciences or an equivalent combination of education, training experience is required /liliPrior experience in Clinical Research and on-site monitoring is required /liliExperience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required /liliExperience in Oncology is required /liliExperience in GI is preferred /liliFull working proficiency in English /liliProficiency in MS Office applications, including MS Project /liliCommunication, presentation and customer-service skills /liliAbility to negotiate and build relationships at all levels /liliTeam building, leadership and organizational skills /lipbFor this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future. /b /pbr/ppbAdditional Information /b /p /ppAdvance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. /ppFor this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future. /p