Clinical Regional Project Lead
Há 20 horas
Job DescriptionThe Regional Project Lead 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 team and 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 met Coordinates 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 & experienceSignificant experience in Clinical Research and site monitoringExperience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalentExperience in Oncology is preferred.Full 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 level while growing with a rapid company, that puts its people firstYou will get hands-on involvement in every aspect of the study.For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
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Regional Project Lead
Há 2 dias
São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro R$120.000 - R$240.000 por anoCompany Description 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 Description The Regional Project Lead manages and coordinates...
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Clinical Project Manager
2 semanas atrás
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Clinical Project Manager****(Level Depends on Experience)****Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...
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Lead Clinical Research Associate
Há 20 horas
São Paulo, Brasil Psi Cro Tempo inteiroJob Description Coordinates investigator/ site feasibility and identification process, as well as study startup.Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.Manages Monitors in the...
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Clinical Team Lead
Há 6 dias
São Paulo, Brasil Fortrea Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in...
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Lead Clinical Research Associate
Há 21 horas
São Paulo, Brasil PSI CRO Tempo inteiroCompany DescriptionPSI 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 DescriptionCoordinates investigator/ site feasibility and...
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Lead Clinical Research Associate
Há 2 dias
São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro R$120.000 - R$240.000 por anoCompany Description 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 DescriptionCoordinates investigator/ site feasibility and...
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Lead Clinical Research Associate
Há 3 dias
São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro R$120.000 - R$240.000 por anoCompany DescriptionPSI 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 Description Coordinates investigator/ site feasibility and...
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Clinical Lead
2 semanas atrás
São Paulo, Brasil IQVIA Tempo inteiroJob OverviewThe Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs,...
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Clinical Lead
Há 4 dias
São Paulo, Brasil IQVIA Tempo inteiroJob OverviewThe Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs,...
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Clinical Project Manager
1 semana atrás
Sao Paulo, Brasil PSI CRO Tempo inteiroCompany Description PSI is a leading Contract Research Organization with more than 25 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 Description**: Take your career to the next level and...
