aCOM-II

MSD; Torre de rádio; On-site; BRL 90,000 - 140,000; Full time

Job summary

MSD in São Paulo seeks a Clinical Operations Associate to support execution and oversight of country submissions and approvals for assigned protocols, and to develop local language informed consent materials.

You will interact with IRB/IEC and regulatory authorities, manage country deliverables, timelines, and ensure quality and compliance, while contributing to local SOP development and cross-functional collaboration.

Qualifications

• Requires Associate degree or equivalent health care related experience.
• Advanced English.
• Bachelor’s degree preferred.

Responsibilities

• Contribute to execution and oversight of country submissions and approvals for assigned protocols.
• Develop local language materials including informed consent forms.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manage country deliverables, timelines and results to meet country commitments with quality and compliance.
• Contribute to local SOP development and training as needed.

Skills

Adaptability

Clinical Research

Clinical Site Monitoring

Project Management

Regulatory Affairs

Negotiation

Communication Skills

Documentation

Risk Management

ICH/GCP

Time Management

Stakeholder Engagement

Education

Associate degree or equivalent health care related experience

Bachelor’s degree (preferred)

Job description

Responsibilities

• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations.
• Interact with IRB/IEC and Regulatory Authority for assign ed protocols.
• Manages country deliverables, timelines and results for assign ed protocols to meet country commitments. Responsible for quality and compliance in assign ed protocols in country.
• Contributes to the development of local SOPs.
• Support of local regulatory and financial compliance. Ability to in/directly influence investigators, external partners and country operations
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, leg al and regional operations, HQ functional areas and externally withvendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions.
• Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Contributes strongly to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Contributes to COM team knowledge by sharing best practices as appropriate/required.
• May act as buddy / mentor

Skills

• Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
• Knowledge of core clinical systems, tools and metrics
• Excellent verbal and written skills, in local language and English
• Strong coordination and organizational skills
• Knowledge of local regulatory environment and submission and approval processes, and understanding of how this impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.
• Ability to make decisions independently with oversight from Sr.COM or Manager.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
• ICH/GCP knowledge appropriate to role.
• Good knowledge of Good Documentation Practices
• Able to work with other experienced clinical research professionals and manage select protocols independently.
• Works with high quality and compliance mindset.
• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and elevate to management as applicable.
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
• High sense of accountability and urgency in order to properly prioritize deliverables
• Strong communication and negotiation skills as well as developing skills in influencing and training/mentoring, both written and verbal, in local language and English.
• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Able to directly influence site staff

Qualification & Experience

• Required: Associate degree or equivalent Health Care related experience
• Advanced english
• Preferred: Bachelor’s degree

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

• Adaptability
• Adaptability
• Business Agility
• Clinical Research
• Clinical Site Monitoring
• Clinical Study Management
• Clinical Trial Compliance
• Competency Management
• Compliance Activities
• Contingency Plan
• Data Analysis
• Drug Development Research
• Good Clinical Data Management Practice (GCDMP)
• Government Regulation
• Influencing Skills
• Interpersonal Relationships
• Management Review
• Negotiation
• New Technology Integration
• Proactive Thinking
• Project Management
• Risk Avoidance
• Root Cause Identification
• Schedule Adherence
• Task Management
• {+ 2 more}

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: 10/31/2026

*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.

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.