Clinical Research Manager

Merck Gruppe - MSD Sharp & Dohme; São Paulo; Presencial; BRL 60.000 - 120.000; Tempo integral

Resumo da oferta

Uma empresa líder no setor farmacêutico está em busca de um Gerente de Pesquisa Clínica para supervisionar o desempenho e o gerenciamento de projetos de ensaios clínicos. Este papel envolve a colaboração com equipes locais e internacionais, garantindo a conformidade com padrões de qualidade e regulamentos. O candidato ideal terá experiência sólida em gestão de pesquisa clínica, especialmente em estudos de imunologia, e um forte entendimento das necessidades de negócios locais. Se você é apaixonado por pesquisa e deseja fazer a diferença em um ambiente dinâmico e inovador, esta é a oportunidade perfeita para você.

Qualificações

• Experiência sólida em gestão de pesquisa clínica e monitoramento de ensaios clínicos.
• Bacharel em Ciências com preferência por grau avançado em ciências.

Responsabilidades

• Ponto de contato principal para protocolos designados e gerenciamento de projetos.
• Responsável por garantir conformidade com ICH/GCP e regulamentos locais.

Conhecimentos

Gestão de Pesquisa Clínica

Monitoramento de Ensaios Clínicos

Gerenciamento de Projetos

Colaboração com Investigadores

Planejamento de Risco

Formação académica

Bacharel em Ciências

Grau Avançado em Ciências/Biologia

Ferramentas

CTMS

eTMF

Descrição da oferta de emprego

Job Description

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, the CRM could be responsible for several countries in a cluster.

Responsibilities include, but are not limited to:

1. Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
2. Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
3. Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
4. Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
5. Performs Quality control visits as required.
6. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
7. Responsible for creating and executing a local risk management plan for assigned studies.
8. Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
9. Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate).
10. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
11. Country POC for programmatically outsourced trials for assigned protocols.
12. Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
13. Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
14. As a customer-facing role, this position will build business relationships and represent company with investigators.
15. Shares protocol-specific information and best practices across countries/clusters.

Experience Requirements:
• Solid experience with Clinical Research management and desirable experience in immunology study.
• Solid previous experience as CRA monitoring clinical trials.

Educational Requirements:
• Bachelor’s degree in Science.

Preferred:
• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology.
• Fluency in English.

ClinicalTrialsBR