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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Country Operations Manager - FSP based in Brazil.
This role sits at the center of clinical trial delivery, ensuring that complex studies are executed efficiently, ethically, and in full compliance with global and local regulations. You will oversee end-to-end operational performance of assigned clinical trials, from planning and feasibility through execution and close-out. Acting as a key leader within a cross-functional and outsourced environment, you will coordinate internal teams, CRO partners, and external stakeholders to ensure trial milestones are met. The role combines strategic oversight with hands-on operational involvement, including risk management, budget control, and quality assurance. You will play a critical part in ensuring patient-centered clinical research is delivered with speed, precision, and integrity. This is a highly collaborative and impact-driven environment where scientific rigor and operational excellence go hand in hand.
Accountabilities:
In this role, you will be responsible for the successful planning, execution, and delivery of clinical trials at the country level, ensuring compliance, quality, and performance across all operational activities:
- Oversee the end-to-end execution of assigned clinical trials, ensuring compliance with ICH-GCP guidelines, local regulations, SOPs, and protocol requirements.
- Lead country-level operational planning, including feasibility assessments, timeline development, and alignment of internal and external stakeholders.
- Manage trial budgets, ensuring accurate forecasting, timely updates, and strong financial oversight throughout study execution.
- Coordinate CROs, vendors, and cross-functional teams to ensure high-quality delivery of trial activities and adherence to agreed milestones.
- Drive site selection, engagement strategies, and recruitment planning to optimize patient enrollment and trial performance.
- Ensure risk identification, mitigation planning, and continuous oversight of trial progress, quality, and safety reporting.
- Support the development of patient-facing materials and incorporate site and patient feedback into trial improvement strategies.
- Provide leadership and guidance to study teams, ensuring training, alignment, and consistent operational excellence across all partners.
Requirements:
The ideal candidate brings strong experience in clinical trial operations and leadership within complex, multi-stakeholder environments, particularly in outsourced or CRO-managed studies:
- Minimum of 5 years of clinical trial management experience within a pharmaceutical, CRO, or life sciences environment.
- Experience managing outsourced studies, CRO partnerships, and vendor oversight in clinical operations.
- Strong understanding of GCP, clinical research regulations, and trial lifecycle management.
- Experience in feasibility assessment, site management, and patient recruitment strategies.
- Background in oncology studies is highly desirable.
- Strong financial acumen with experience managing study budgets and operational forecasting.
- Excellent leadership, communication, and stakeholder management skills across global and local teams.
- Academic background in life sciences, nursing, medicine, or related scientific discipline (BSc/MSc/PhD preferred).
Benefits:
- Competitive compensation aligned with experience and industry standards in Brazil
- Remote-first working model with flexibility
- Opportunity to work on global clinical trials impacting patient outcomes worldwide
- Exposure to leading biopharmaceutical clients and innovative drug development programs
- Strong career development opportunities within a global clinical research environment
- Comprehensive health and wellness benefits package (where applicable)
- Collaborative, mission-driven culture focused on improving global health outcomes
- Participation in high-impact, patient-centered research initiatives.
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