Senior Clinical Trial Manager

Bristol-Myers Squibb; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

Uma empresa farmacêutica global está em busca de um(a) Clinical Trial Manager para supervisionar ensaios clínicos no Brasil. O(a) candidato(a) ideal deve ter experiência em gestão de projetos, habilidades de comunicação e capacidade de trabalhar com equipes variadas. Este papel envolve desde a coordenação com equipes até a implementação de estratégias de recrutamento e solução de problemas, sempre garantindo o cumprimento de prazos e padrões de qualidade.

Serviços

Oportunidades de crescimento

Ambiente inclusivo

Qualificações

• Experiência em ensaios clínicos e gestão de estudos desejável.
• Capacidade de trabalhar com equipes multifuncionais.
• Conhecimento em sistemas de gestão de ensaios clínicos (CTMS).

Responsabilidades

• Gerenciar a coordenação entre os membros da equipe de estudo global.
• Implementar o processo de viabilidade do estudo no país.
• Planejar e executar cronogramas para o início do estudo.
• Garantir que as metas de inscrição sejam atendidas.

Conhecimentos

Gestão de projetos

Habilidades de comunicação

Gestão de risco

Formação académica

Graduação em Ciências da Saúde ou áreas relacionadas

Descrição da oferta de emprego

Working with Us

Challenging.

Meaningful.

Life‑changing.

Those aren't words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual.

Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams.

Take your career farther than you thought possible.

A BMS acredita que ter uma equipe diversificada de funcionários e uma cultura de inclusão é vital para a inovação e para executar de forma bem‑sucedida nossa estratégia de negócios BioPharma.

Todas as nossas oportunidades são abertas para pessoas com deficiência (PCD), assim como para as demais dimensões no sentido mais amplo da diversidade, como gênero, idade, etnia, raça, orientação sexual & identidades, habilidades físicas, aparência, religião, origem socioeconômica, estilos de pensamento e experiências de vida.

Position Summary

The Clinical Trial Manager (CTM) is accountable for end‑to‑end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

Key Responsibilities

• Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross‑functional teams.
• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
• Plans, develops and executes timelines and activities for start‑up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
• Implement country and site level patient recruitment strategy and risk mitigation.
• Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
• Assessment and set up the of vendors during study start‑up period (locally)
• Investigator Meeting participation and preparation.
• Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel.
• This includes entering necessary data and uploading documents in eTMF.
• Validation of study related materials (i.e. protocol, ICF, patient material).
• Supports the review of country and site‑specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
• May support preparation of materials for Site Initiation Visits.
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
• Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
• Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow‑up.
• Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country.
• Provide support to Health Authority inspection and pre‑inspection activities.
• Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings.
• Drives CAPA review, implementation and completion.
• Coordinate study team meetings locally.
• Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).
• Collaborates with the local study team to support the management of site relationships (may include CRO related issues).
• May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
• May perform site closure activities, including post‑close out.
• May act as point of contact for Sites.
• As required per country requirements, perform or support the preparation of submissions to Health Authorities including follow‑up until approval.
• This includes substantial amendments and any other documentation requiring HA submission.
• Perform submission to Ethics Committees and governance offices, where applicable, including follow‑up until approval (protocol, amendments / IB and any other documents requiring EC submission).
• Coordinate the MOH responses with regulatory and central teams, as applicable.
• May support the co