Clinical Research Manager

3413 Merck Sharp & Dohme Farmaceutica Ltda; São Paulo; On-site; BRL 300,000 - 420,000; Full time

Job summary

Merck & Co., Inc. seeks a Clinical Research Manager to lead end-to-end execution of sponsor-led trials in Brazil, ensuring ICH/GCP compliance and country regulations.

The CRM will manage feasibility, site selection, recruitment, execution, and close-out while collaborating with country operations, QA, PV, and regulatory teams. The role requires hands-on management of Phase I–III studies, strong project management and risk skills, and English proficiency.

Qualifications

• Requires hands-on, end-to-end sponsor-led trial experience (Phase I–III).
• Strong knowledge of ICH-GCP, regulations, and quality standards.
• Proven ability to manage complex trials and cross-functional teams.

Responsibilities

• Serve as main point of contact for assigned protocols and connect Country Operations to the clinical trial team.
• Plan, drive and track study deliverables, timelines, and country commitments from feasibility to close-out.
• Ensure compliance with ICH-GCP, country regulations, and company policies across studies.
• Review monitoring visit reports and escalate issues to management and vendors as needed.
• Lead local study teams, train roles on protocols, and coordinate activities across country roles.
• Develop and execute local risk management plans for assigned studies.

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

Education

Bachelor degree in Science (or comparable)

Advanced degree (Master/MD/PhD)

Job description

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

• 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 Qualifications

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

Preferred Qualifications

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

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

Company Culture

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 diversificadas 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 Information

Additional location(s)

Compensation Information:

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

Company Overview

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.