About the Role
As a Global Contract Clinical Trial Manager within the Clinical Operations team, you will play a key role in the planning, execution, and management of clinical trials conducted across multiple global sites. You will collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and external vendors to ensure successful study execution in accordance with regulatory requirements and company standards. Reporting to the Associate Director, Clinical Operations, this individual will provide hands-on operational leadership across global oncology studies.
Responsibilities
• Develop and execute comprehensive global site management plans, including timelines, budgets, and resource allocation
• Oversee site selection, initiation, and monitoring activities while ensuring compliance with GCP, study protocols, and applicable regulations
• Coordinate with CROs, central laboratories, and other study vendors to ensure timely and high-quality delivery of study activities
• Manage trial-related documents including protocols, investigator brochures, informed consent forms, and regulatory submissions
• Implement risk mitigation strategies and proactively identify and resolve study issues and deviations
• Serve as a primary point of contact for investigative sites throughout the life of the study
• Function as a subject matter expert for clinical systems such as eTMF and CTMS, as needed
• Contribute to process improvements and operational best practices within Clinical Operations
• Remain current on industry trends, regulatory guidance, and emerging technologies that impact clinical trial execution
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Qualifications
• B.S. / B.A. in Life Sciences or a related field
• 6+ years of clinical trial management experience within biotechnology, pharmaceutical, or CRO environment
• Phase I–III oncology experience
• Phase I–III global trial management experience
• Direct experience overseeing global CROs and study vendor
• Strong organizational skills and attention to detail
• Excellent written and verbal communication skills
• Ability to establish priorities, manage multiple activities, and work effectively in a fast-paced environment
• Strong problem-solving skills and sense of urgence
• Experience using CTMS, eTMF, IRT, EDC platforms, and Microsoft Office application
• Ability to work across cultures and multiple time zone
• Self-motivated and adaptable within a small, growing organization
Preferred Skills
• 6+ years of on-site monitoring experience