PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionThe 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.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 countriesPerforms study status review and progress reporting (if delegated by the Project Manager)Collects and reports project status updates for designated regions, both internally and externallyDevelops and updates project planning documents, essential study documents and project manuals/ instructionsManages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team membersEnsures that the project timelines and subject enrollment targets are met in designated countriesCoordinates maintenance of study-specific and corporate tracking systemsCoordinates site contractual startup and budget negotiationsEstablishes communication lines within the project teamand supervises clinical project team members’ performanceIdentifies,



escalates and resolves resourcing and performance issuesConducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)Prepares presentations and conducts training of InvestigatorsEnsures team compliance with project-specific training matrixPerforms field training of Monitors tailored to the project needsSupervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visitsOversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution processSupervises project team preparation for study audits/ inspections and resolution of audit/ inspection findingsCoordinates conduct of supervised monitoring visitsReviews site visit reports and ensures monitoring and reporting standards are metCoordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notificationsOversees the safety information flow and participates in feasibility researchReviews/approves project related expenses and timesheets (if delegated by the Project Manager)QualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experience is requiredPrior experience in Clinical Researchand on-site monitoring is requiredPrior experience monitoring within the USExperience as a Study Manager/Clinical Trial Managerwith theability to supervise project activities as a Regional Lead or equivalent is requiredExperience in Oncology is requiredExperience in GI is preferredFull working proficiency in EnglishProficiency in MS Office applications, including MS ProjectCommunication, presentation and customer-service skillsAbility to negotiate and build relationships at all levelsTeam building, leadership and organizational skillsAdditional InformationAdvance your career in clinical research and lead challenging full-service projects on the country/regional levelwhile growing with a rapidcompany, that puts its people first! You will get hands-on involvement in every aspect of the study.#J-18808-Ljbffr

📌 Clinical Regional Project Lead (Santiago)
🏢 Psi Cro
📍 Santiago