Job Title: Clinical Operations Manager
Employment Type: Full-Time | Regular
Work Region: Europe, Middle East, Africa, Latin America & Asia Pacific
Job Posting End Date: 30 January 2026
Flexible Work Arrangements: Not Applicable
A leading global biopharmaceutical organization is seeking an experienced Clinical Operations Manager (COM) to oversee country-level clinical trial execution, compliance, and financial performance. This role is critical to ensuring successful study start-up, regulatory submissions, site readiness, and ongoing trial delivery in compliance with ICH-GCP, local regulations, and internal quality standards.
The Clinical Operations Manager will have end-to-end accountability for assigned protocols within a country, including budget ownership, regulatory approvals, vendor oversight, and cross-functional collaboration with global and regional stakeholders.
Clinical Trial Operations & Compliance
Ensure country-level performance and compliance for assigned protocols in line with ICH-GCP, local regulations, company SOPs, and adverse event reporting requirements.
Execute and oversee clinical trial country submissions, regulatory approvals, and site readiness activities.
Manage interactions with Regulatory Authorities, IRB/IEC, investigators, and external partners.
Maintain ownership of local regulatory and financial compliance throughout the study lifecycle.
Budget, Finance & Contracts
Own country and site budgets, including development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).
Oversee clinical research payments, payment reconciliation at study closeout, and financial forecasting.
Ensure compliance with FCPA, DPS/OFAC requirements, and maintenance of financial systems.
Country & Site Management
Manage country deliverables, timelines, and milestones to meet protocol and business commitments.
Coordinate with CRAs, CTCs, CRM, Finance, Legal, Pharmacovigilance, Regulatory Affairs, and HQ teams to align country and global timelines.
Oversee local vendors, clinical supplies, import/export requirements, insurance processes, archiving, and retention activities.
Leadership & Process Excellence
Lead and mentor Clinical Trial Coordinators (CTCs) as applicable.
Act as a Subject Matter Expert (SME) for country operations, sharing best practices and driving continuous improvement.
Contribute to or lead strategic initiatives and projects that add business value.
Strong expertise in clinical trial systems, tools, metrics, and country operations processes.
Advanced knowledge of budget management, contract negotiations, and regulatory submission pathways.
Proven ability to independently manage risks, develop mitigation strategies, and resolve country-level issues.
Excellent communication, influencing, and stakeholder management skills in both local language and English.
Ability to lead teams, manage multiple protocols, and work effectively in a global virtual environment.
Strong problem-solving mindset with the ability to proactively identify risks and implement solutions.
High accountability, urgency, and ability to prioritize complex deliverables.
Effective time management, negotiation, conflict resolution, and leadership skills.
Self-driven, adaptable, and capable of working independently with minimal oversight.
Minimum 5 years of experience in clinical research, or a combination of clinical research and finance/business experience.
Demonstrated experience in country-level clinical operations, study start-up, and regulatory submissions is essential.
Bachelor’s degree in Life Sciences, Business Administration, Finance, or a related healthcare discipline.
Equivalent healthcare-related experience may be considered.
Clinical Operations Management, Clinical Research, ICH-GCP Compliance, Clinical Trial Start-Up, Country Operations, Budget Forecasting, Clinical Trial Agreements (CTA/CTRA), Regulatory Submissions, Site Management, Vendor Oversight, Risk Management, Financial Administration, Cross-Functional Collaboration, Global Clinical Trials.
The organization is committed to fostering a diverse, inclusive, and compliant workplace. All qualified applicants will receive equal consideration without regard to race, gender, disability, age, or other protected characteristics.
Gujarat :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rabigh | Khulais | Riyadh | Najran | King Abdullah Economic City | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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