aCOM-II

Merck; São Paulo; On-site; BRL 180,000 - 300,000; Full time

Job summary

Merck Brazil is seeking a Senior Clinical Operations Manager to oversee country-level submissions, regulatory interactions, and contract deliverables for assigned protocols in Brazil. You will lead cross-functional teams across regulatory, finance, and clinical operations to ensure quality, compliance, and timely study milestones.

The role emphasizes strong coordination, local language document development, and mentorship within COM.

Qualifications

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

Responsibilities

• Contribute to execution and oversight of country submissions for assigned protocols.
• Develop local language informed consent materials and translations.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manage country deliverables, timelines and results to meet country commitments.
• Support local regulatory and financial compliance and influence investigators and vendors.

Skills

MS Office

Clinical IT

Regulatory knowledge

English proficiency

Project coordination

Education

Associate degree

Bachelor's degree

Job description

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.

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}

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