Clinical Research Manager

Merck Gruppe - MSD Sharp & Dohme; São Paulo; Híbrido; BRL 260.000 - 420.000; Jornada completa

Descripción de la vacante

Merck Gruppe - MSD Sharp & Dohme in Brazil is seeking a Clinical Research Manager to lead end-to-end execution of sponsor-led Phase I–III trials in Brazil, ensuring ICH/GCP compliance and country regulations. You will coordinate with Country Operations and the clinical trial team to drive delivery and quality.

The role requires strong project management, risk handling, and cross-functional collaboration with PV, Regulatory and GMA as needed. Hybrid work arrangement is available.

Formación

• Proven hands-on experience in end-to-end management of sponsor-led Phase I–III clinical trials.
• Experience with large-scale or megatrials.
• Strong knowledge of ICH-GCP and quality standards.
• Bachelor degree in Science (or comparable) and English proficiency.
• Advanced degree preferred.

Responsabilidades

• Main POC for assigned protocols linking Country Operations and clinical trial team.
• Plan, drive and track execution and performance to meet country commitments.
• Ensure compliance with ICH/GCP and country regulations and company policies.
• Lead local study teams; train roles and coordinate activities across country roles.
• Ensure CTMS/eTMF compliance and quality; escalate issues as needed.

Conocimientos

Clinical Data Management

Clinical Research

Clinical Site Management

Clinical Trial Management

Good Clinical Practice (GCP)

Risk Based Monitoring

Strategic Planning

Strategic Thinking

Vendor Management

Educación

Bachelor degree in Science

Advanced degree (MD/PhD/Master)

Descripción del empleo

Job Description

Our Global Clinical Trial team is at the heart of advancing our clinical development portfolio, turning science into meaningful outcomes for patients. We are looking for a Clinical Research Manager (CRM) to drive the end-to-end execution of clinical studies in Brazil.

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, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities include, but are not limited to

Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

• 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.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required
• 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
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)

Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies

• Country POC for programmatically outsourced trials for assigned protocols.
• 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.
• As a customer-facing role, this position will build business relationships and represent Our Company with investigators
• Shares protocol-specific information and best practices across countries\clusters

Required Experience

• Proven hands-on experience in end-to-end management of sponsor-led Phase I–III clinical trials, beyond site monitoring activities.
• Experience managing large-scale and/or highly complex clinical trials, including megatrials.
• Experience with complex study designs and operational models, with greater emphasis on study type, scale and complexity than on a specific therapeutic area.
• Strong knowledge of ICH-GCP, clinical research regulations and quality standards.
• Strong project management, risk management and cross-functional stakeholder management capabilities

Required

• Bachelor degree in Science (or comparable)
• English Proficiency

Preferred

Advanced degree, (e.g., Master degree, MD, PhD)

"Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado."

Additional location(s) Compensation Information:

Required Skills:

Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management, Good Clinical Practice (GCP), Risk Based Monitoring, Strategic Planning, Strategic Thinking, Vendor Management

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 11/18/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.