Country Study Operations Manager I - FSP in Brazil, Indiana at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Country Study Operations Manager I – FSP based in Brazil.

This role is a key driver of country-level clinical study execution across startup, conduct, and close-out phases within global clinical trials.
You will be responsible for coordinating and overseeing operational activities across assigned countries, ensuring studies are delivered on time, within scope, and in compliance with regulatory requirements.
The position plays a central role in aligning local execution with global study strategy, working closely with cross-functional teams, vendors, and site stakeholders.
You will support study startup activities, recruitment strategies, and site activation processes while managing risks and resolving operational issues.
A strong focus of the role is ensuring data quality, inspection readiness, and adherence to ICH-GCP and internal standards.
You will act as a key liaison between global and local teams, providing country intelligence and operational insight.
This is a highly collaborative and impactful role where operational excellence directly supports successful clinical trial delivery worldwide.

• Lead and coordinate country-level study activities across startup, execution, and close-out phases, ensuring alignment with global study objectives.
• Oversee local study teams, pCROs, and site partners to ensure timely delivery of study milestones, recruitment targets, and operational deliverables.
• Support and/or manage study startup activities, including regulatory and ethics submissions, site activation, and feasibility assessments.
• Monitor and manage study timelines, risks, budgets, quality plans, and escalation processes at country level.
• Ensure effective communication between global and local study teams, providing updates, issue resolution, and operational guidance.
• Drive recruitment and site engagement strategies in collaboration with cross-functional stakeholders.
• Ensure inspection readiness, TMF completeness, and compliance with ICH-GCP, SOPs, and regulatory requirements.
• Support vendor oversight, data cleaning activities, and study close-out processes where applicable.

• Bachelor’s degree with 5+ years of relevant clinical research or study operations experience, or Master’s degree/MBA with 3+ years of experience.
• Strong background in clinical trial operations, study coordination, or startup/project management in a global environment.
• Solid understanding of ICH-GCP guidelines, clinical development processes, and regulatory requirements.
• Experience working with country-level study execution, vendors, or CRO oversight is highly valued.
• Strong analytical, organizational, and problem-solving skills with the ability to manage complex operational tasks.
• Excellent communication skills, with fluency in written and spoken English required.
• Ability to work in matrixed, global environments and manage competing priorities effectively.
• Willingness to support global trial timelines, including occasional flexible working hours and travel.

• Competitive compensation aligned with clinical operations expertise
• Opportunity to contribute to global, high-impact clinical trials
• Remote-friendly work arrangements depending on assignment
• Exposure to international study management and cross-functional teams
• Career development in clinical operations and study management leadership pathways
• Involvement in complex, multinational research programs
• Collaborative, knowledge-driven global working environment