About the Role
We are seeking an experienced Clinical Trial Manager to lead the operational delivery of international clinical studies across multiple phases. This role will be responsible for overseeing study execution from start-up through close-out, ensuring timelines, budgets, quality standards, and regulatory requirements are consistently achieved.
The successful candidate will work cross-functionally with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, Pharmacovigilance, external CROs, and investigative sites to ensure efficient and compliant study delivery within a highly regulated biopharmaceutical environment.
Key Responsibilities
Lead the day-to-day management of global and regional clinical trials from initiation through completion
Oversee study timelines, budgets, risks, and deliverables to ensure successful execution
Manage CROs, vendors, and external partners, including performance oversight and issue escalation
Coordinate cross-functional study teams and drive operational alignment across stakeholders
Ensure studies are conducted in compliance with ICH-GCP, SOPs, FDA, EMA, and applicable regulatory requirements
Support protocol development, study planning, feasibility assessments, and study start-up activities
Monitor study progress, patient recruitment, data quality, and site performance metrics
Review and contribute to study documents including protocols, informed consent forms, monitoring plans, and clinical study reports
Identify operational risks and implement mitigation strategies proactively
Support inspection readiness and participate in audits and regulatory inspections as required
Maintain accurate clinical trial documentation within CTMS and eTMF systems
Requirements
Bachelor’s degree in Life Sciences or related scientific discipline; advanced degree preferred
Proven experience managing clinical trials within a pharmaceutical, biotechnology, or CRO environment
Strong knowledge of ICH-GCP guidelines and global clinical trial regulations
Experience overseeing Phase I–III clinical studies
Demonstrated ability to manage vendors, CROs, and cross-functional stakeholders
Strong project management and organizational skills with the ability to manage multiple priorities
Experience with clinical systems such as CTMS, eTMF, EDC, or Veeva preferred
Excellent communication and stakeholder management skills
Fluent English required; additional European languages are advantageous
Preferred Experience
Experience within plasma-derived therapies, hematology, immunology, rare disease, or biologics environments
Exposure to global, multi-center clinical studies
Experience supporting regulatory inspections and audit readiness
What We Offer
Opportunity to work within a growing international biopharmaceutical environment
Exposure to innovative and complex clinical development programs
Collaborative and highly cross-functional culture
Competitive compensation and benefits package
Long-term career development opportunities within Clinical Operations and Global Development
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