Advanced Clinical | Sr Clinical Trial Manager | Brasil

Detalhes da Vaga

Freelance Clinical Trial Manager looking after LATAMOncology-focused Midsized Pharma Company The role will focus on vendor management and site engagement in LATAM for the Phase III global clinical trial.SummaryThe Senior Clinical Trial Manager oversees clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements. They collaborate with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. Additionally, they may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.Participate in the planning, implementing, and managing clinical trials in compliance with industry regulations and ICH-GCP. - Oversee CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.Track site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation. - Assist in initiation visits to confirm site training and foster relationships among sponsors, CROs, and investigators.Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.Collaborate with teams for efficient study start-up, identifying risks and ensuring timelines are met.Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.Could you provide direction to ensure consistency in Clinical Operations processes across trials and regions?Work cross-functionally with departments to meet study requirements and timelines.Contribute to developing and reviewing study-related documents and deliver trial-specific training.Monitor open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.Develop and oversee patient recruitment and retention strategies, acting on any deviations from the plan.ExperienceMinimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and/or CROs.Strong understanding of GCP, ICH, GDP, relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.Experience with clinical trial site start-up and initiation.Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.Strong communication skills for coordinating activities with internal teams, sites, and vendors.Proactive in identifying project challenges and proposing corrective actions with minimal supervision.Capable of working independently and delivering high-level presentations.Knowledge and experience in oncology.Previous experience as a Clinical Research Associate (CRA).


Salário Nominal: A acordar

Fonte: Whatjobs_Ppc

Função de trabalho:

Requisitos

Medico Do Trabalho Passos Mg

Estudar as condicoes de saude no trabalho dos colaboradores executar outras tarefas compativeis com as exigencias para o exercicio da funcao


Grupo Afonso França - Minas Gerais

Publicado 5 days ago

Farmaceutico Oncologico Hospital

Manipular e dispensar medicamentos antineoplasicos conforme as normas tecnicas a fim de garantir rastreabilidade e seguranca para os pacientes em toda a


Unimed Juiz De Fora - Minas Gerais

Publicado 5 days ago

Tecnicoa De Enfermagem Central De Movimentacao

Atuar dentro dos padroes de qualidade bem como auxiliar no desenvolvimento das atividades assistenciais relativas ao transporte


Santa Casa Bh - Minas Gerais

Publicado 5 days ago

Enfermeiroa 3

Descricao o que voce precisa ter experiencia na area de enfermagem do trabalho sera considerado diferencial pacote office intermediario conhecimento


Netvagas (6919661019) - Minas Gerais

Publicado 5 days ago

Built at: 2024-11-25T22:50:34.640Z