Jobgether
Country Study Operations Manager I - FSP
TLDR
Leads country-level study operations across startup, execution, and close-out, ensuring timely delivery, regulatory compliance, and alignment with global study strategy.
Accountabilities:
- 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
Requirements:
Benefits:
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Benefits
Remote-Friendly
Remote-friendly work arrangements depending on assignment
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services
Operations Manager