Job Description

The Head of Country Clinical Trial Operations is responsible for the execution and oversight of local operational clinical trial activities, ensuring full compliance with the International Council for Harmonisation Good Clinical Practice (ICH-GCP), applicable country regulations, company policies, procedures, and both internal and external quality standards.

The person in this role will take ownership and provide oversight of local regulatory and financial compliance, including management of out-tasking activities as applicable.

The core responsibility is to lead and manage the strategy and execution of all regulatory, financial, and logistical aspects related to insourced clinical studies.

Primary responsibility for the role includes:

• The role will manage Senior Clinical Operation Managers, Clinical Operation Managers, and Clinical Trial Coordinators within the countries/clusters, based on specific country requirements.

• Manages direct reports including performance plans and development plans. Oversee the performance management and career development of staff and effectively manage performance issues.

• Work closely with Country Research Directors, Heads of Site Management and Monitoring/Clinical Research Associate Managers and TA-Heads to assess program strategy and alignment of project deliverables and objectives.

• Partners with Headquarters based colleagues to help drive company strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Central

  Institutional Review Board and applicable Health Authorities.

• Create, promote, and direct a strategy for rapid start up activities.

• Establish country procedures and processes for all relevant activities (managing site contracts and budget negotiation and escalation, regulatory submissions and approvals; procedures and processes for managing logistics and purchasing of drugs and materials for study start up.)

• Responsible to ensure all projects are adequately resourced and tracked to ensure optimal efficiency and attainment of goals, milestones, and targets while ensuring high quality standards are maintained.

• Establishing a strategy for partnering and monitoring all vendors/service providers that support operational implementation and management of Senior Clinical Operation Managers, Clinical Operation Managers , and Clinical Trial Coordinators responsibilities (including contractors, vendors, etc)

Qualifications, Skills & Experience
• Minimum Education: Bachelor of Science degree - Preference of Master of Science or Medicine (or comparable);
• 10-12 years of relevant clinical research or operational experience;
• Familiar with ICH/GCP principles and all related national regulations
• Working with multiple external partners with adequate controls, governance, and oversight
• Proven experience with Leadership and people management
• Knowledge and experience managing personnel and processes in a matrix managed organization
• Knowledge and experience in all clinical trial startup and ongoing management activities and processes
• Knowledge and awareness of clinical trial operations from a clinical research site perspective

Location: São Paulo/SP (Hybrid)
Extent of Travel: 10-15%

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Clinical Operations, Clinical Risk Management, Clinical Supplies Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Operations, Core Competencies, Decision Making, Emotional Intelligence, Ethical Standards, Human Resource Management, ICH GCP Guidelines, Liaison Between Departments, Management Process, Multiple Therapeutic Areas, People Leadership, Process Improvements, Professional Networking, Regulatory Management, Regulatory Strategies, Resource Allocation, Strategic Thinking, Strategy Development

Preferred Skills:

Finance Management Services

Job Posting End Date:

07/12/2025

*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.