The posting
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
Preferred Skills:
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Search Firm Representatives Please Read Carefully 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. Please, no phone calls or emails.
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.
