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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