Assoc. Dir, Clin. Operations

MSD; São Paulo; On-site; BRL 220,000 - 320,000; Full time

Job summary

MSD is seeking an experienced Clinical Project Manager for interventional trials in Brazil. You will act as the main contact for assigned protocols and bridge Country Operations with the Clinical Trial Team, driving execution, timelines, and deliverables to meet country commitments.

You will ensure compliance with ICH/GCP, manage cross-functional collaboration, and lead local study teams to high performance while building relationships with investigators and external partners.

Qualifications

• Experience in Clinical Research.
• Solid experience as a Clinical Project Manager for interventional trials.
• CRA experience.
• Advanced English proficiency.

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: plans, drives, and tracks execution and performance to meet country commitments.
• Accountable for performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards, and adverse event reporting requirements.
• Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA Manager and/or vendors.

Skills

Adaptability

Clinical Data Mgmt

Clinical Research

Clinical Site Mgmt

Clinical Trial Mgmt

Customer Communications

Decision Making

GCP

Prioritization

Project Management

Risk Based Monitoring

Risk Management

Strategic Planning

Strategic Thinking

Task Management

Team Leadership

Vendor Management

Education

Bachelor’s degree in Science

Advanced degree (MD/PhD)

Job description

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: proactively 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 of assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visit 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 other local roles on the protocol, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles, ensuring 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 challenges and issues as needed to TA Head/CRD/CQM and/or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (if delegated, can sign contracts and manage budgets).
• 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.

Qualifications & Experience Required

• Experience in Clinical Research.
• Solid experience as a Clinical Project Manager for interventional trials.
• CRA experience.
• Advanced English proficiency.

Educational Requirements

• Bachelor’s degree in Science (or comparable).
• Advanced degree (e.g., Master's 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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): no

Job Posting End Date: 10/27/2026

Required Skills

• Adaptability
• Clinical Data Management
• Clinical Research
• Clinical Site Management
• Clinical Trial Management
• Customer Communications
• Decision Making
• Good Clinical Practice (GCP)
• Prioritization
• Project Management
• Risk Based Monitoring
• Risk Management
• Strategic Planning
• Strategic Thinking
• Task Management
• Team Leadership
• Vendor Management

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.