Senior Clinical Trial Manager

trial activities, and contribute to the execution of high-quality global studies. This position plays an important role in operational planning, trial oversight, regulatory compliance, and ensuring studies are delivered efficiently and according to established timelines and quality expectations.

This role involves hybrid onsite collaboration, with a minimum of three days per week working from either our San Francisco or New Jersey location.

Looking for bilingual candidates in Mandarin, Cantonese, or Japanese.

Key Responsibilities
• Partner with study leadership to oversee day-to-day operational execution of international clinical trials managed internally, ensuring data quality, adherence to timelines, and budget alignment
• Design and implement operational strategies supporting oncology trial delivery from initiation through completion
• Work closely with multidisciplinary teams—including clinical science, regulatory affairs, data management, and investigative sites—to enable efficient study conduct and high-quality outputs
• Direct study start-up activities such as feasibility, site identification, and preparation of essential trial documentation in collaboration with operational support functions
• Coordinate site activation, training, and monitoring activities to maintain compliance with study protocols, regulatory standards, and Good Clinical Practice requirements
• Build productive relationships with investigators and site personnel to support enrollment goals and ongoing site engagement
• Track study performance metrics, proactively identifying risks or operational challenges and implementing mitigation strategies
• Maintain compliance with applicable regulatory frameworks, including FDA regulations and ICH-GCP standards, throughout the clinical trial lifecycle
• Oversee vendor performance and collaboration with external partners such as CROs, laboratories, and imaging providers
• Contribute to authoring and reviewing essential study documents including protocols, informed consent forms, CRFs, and operational procedures
• Develop study processes and materials that ensure consistent execution and administrative compliance
• Maintain oversight of study documentation, including sponsor Trial Master File management and periodic quality reviews

Qualifications
• PhD with 3+ years, Master’s degree with 6+ years, or Bachelor’s degree with 8+ years of relevant clinical research experience
• Demonstrated background in Clinical Operations; oncology clinical trial experience strongly preferred
• Strong understanding of global clinical research regulations and industry standards, including ICH-GCP and FDA requirements
• Experience managing trials across the full study lifecycle, from start-up through closeout
• Proven project management capabilities, including timeline planning, prioritization, and resource coordination
• Excellent communication and stakeholder management skills across cross-functional and global teams
• Strong analytical mindset with the ability to anticipate and resolve operational risks
• Experience using clinical trial management platforms such as Veeva CTMS or similar systems
• Familiarity with oncology indications, treatment approaches, and clinical terminology
• Ability to work onsite at least three days per week