aCOM-II

MSD; São Paulo; In loco; BRL 180.000 - 360.000; Tempo pieno

Descrizione del lavoro

MSD Brazil is seeking a capable clinical operations professional to manage country submissions, create local language ICFs, and interact with IRBs/Regulatory Authorities. You will oversee timelines, ensure quality/compliance, and support local SOP development with cross-functional teams.

Ideal candidates have a healthcare background, advanced English, and the ability to influence investigators and partners.

Competenze

• Associate degree or health care related experience required.
• Advanced English proficiency is required.
• Bachelor’s degree preferred.

Mansioni

• Contribute to execution and oversight of 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 to meet commitments with quality and compliance.
• Contribute to development of local SOPs and training as needed.
• Support local regulatory and financial compliance and influence stakeholders to resolve issues.

Conoscenze

Adaptability

Business Agility

Clinical Research

Clinical Site Monitoring

Clinical Study Management

Clinical Trial Compliance

Data Analysis

GCDMP

Government Regulation

Influencing Skills

Interpersonal Relationships

Management Review

Negotiation

Project Management

Risk Avoidance

Root Cause Identification

Schedule Adherence

Task Management

Proactive Thinking

New Technology Integration

Formazione

Associate degree or Health Care related experience

Advanced English

Bachelor’s degree

Strumenti

MS Office

Clinical IT applications

Descrizione del lavoro

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
• 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.

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}

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: 10/31/2026*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.