aCOM-II

Merck Gruppe - MSD Sharp & Dohme; São Paulo; Hybrid; BRL 120,000 - 180,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in São Paulo, Brazil seeks a proactive professional to oversee country submissions for clinical trials, develop local consent materials, and liaise with IRB/Regulatory Authorities. You will manage country deliverables, ensure quality and compliance, and contribute to SOP development.

Strong English, regulatory knowledge, and cross-functional collaboration are essential for success.

Qualifications

• Required: Associate degree or equivalent Health Care related experience.
• Advanced English proficiency.

Responsibilities

• Contribute to execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Develop local language materials including informed consents and translations.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manage country deliverables, timelines and results for assigned protocols to meet country commitments; ensure quality and compliance.
• Contribute to the development of local SOPs.
• Support local regulatory and financial compliance; influence investigators and external partners.
• Collaborate with GCTO country operations, finance, regulatory affairs, pharmacovigilance, and regional HQ units; interact with vendors, sites, IRBs and authorities.
• Deliver clinical and financial contracts within fair market value.
• Lead initiatives and projects adding value to the business; share SME knowledge and provide training as appropriate.
• Mentor and support COM team knowledge sharing and best practices.

Skills

IT skills

Clinical IT applications

Core clinical systems

Verbal and written English

Coordination skills

Organizational skills

Regulatory environment knowledge

Risk management

Problem solving

Time management

Negotiation skills

Influencing and mentoring

Education

Associate degree or equivalent Health Care related experience

Advanced English

Bachelor’s degree (preferred)

Tools

MS Office

Job description

Job Description

Responsibilities include, but are not limited to:

• 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

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}

Responsibilities include, but are not limited to:

• 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.

#LI-DNI

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 job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R423264