【Relocate to the U.S.】Clinical Project Manager / Clinical Research Director

【Company Description】

We are seeking an experienced and strategic clinical operations leader to oversee late-stage global clinical development programs. This individual will play a critical role in managing Phase III multi-center clinical trials in the United States and leading collaboration with global CRO partners.

【Required Qualifications】

• Bachelor’s degree or above in Life Sciences, Pharmacy, Nursing, or related scientific discipline; advanced degree preferred.
• Minimum 10+ years of clinical operations experience within biotech, pharmaceutical, or CRO industries.
• Prior experience managing or overseeing global CRO organizations is required.
• Strong hands-on experience leading Phase III clinical trials, preferably multinational or multi-center studies in the U.S.
• Demonstrated expertise in clinical project management, including study budgeting, forecasting, timeline management, and resource allocation.
• Experience independently managing cross-functional clinical study teams.
• Solid understanding of FDA regulations, ICH-GCP guidelines, and clinical trial processes.
• Strong communication, stakeholder management, and vendor negotiation skills.
• Ability to work effectively in a fast-paced, global matrix organization.

【Preferred Qualifications】

• Experience in oncology, rare disease, obstetrics and gynecology (OB/GYN), or other complex therapeutic areas preferred.
• Previous experience in a Clinical Project Manager or Global Clinical Trial Manager capacity strongly preferred.
• Experience supporting NDA/BLA-enabling studies is a plus.
• Familiarity with eTMF systems, CTMS platforms, and clinical trial financial tracking tools.
• Open for Taiwanese who has worked in the U.S, or Taiwanese talents who want to be relocated to the U.S.

【Key Responsibilities】

• Lead and oversee Phase III clinical trials conducted across multiple investigational sites in the United States.
• Serve as the primary operational lead for global CRO management, including vendor oversight, performance management, and strategic partnership alignment.
• Develop and manage clinical study timelines, budgets, resource planning, and operational deliverables to ensure successful study execution.
• Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, and Quality teams.
• Ensure clinical trials are conducted in compliance with ICH-GCP, FDA regulations, SOPs, and applicable regulatory requirements.
• Identify operational risks proactively and implement mitigation strategies to maintain study quality and timelines.
• Oversee study milestones including site selection, study start-up, patient enrollment, monitoring, database lock, and close-out activities.
• Support inspection readiness and audit activities related to clinical operations.