Senior Clinical Trial Operations Manager

ical trial activities, while ensuring the successful execution of top-notch global studies. This pivotal role involves operational planning, oversight of trials, regulatory compliance, and guaranteeing that studies are efficiently delivered to meet established timelines and quality standards.

This position requires a blend of onsite and remote collaboration, with at least three days a week at our San Francisco or New Jersey office.

We welcome bilingual candidates fluent in Mandarin, Cantonese, or Japanese.

Key Responsibilities
• Collaborate with study leadership to ensure the smooth operation of international clinical trials, focusing on data integrity, timeline adherence, and budget management.
• Develop and execute operational strategies that facilitate the delivery of oncology trials from initiation to completion.
• Work in tandem with multidisciplinary teams—spanning clinical science, regulatory affairs, data management, and investigative sites—to enable effective study execution and produce high-quality outcomes.
• Lead study start-up activities, including feasibility assessments, site identification, and preparation of necessary trial documents with operational support.
• Manage site activation, training, and monitoring efforts to ensure compliance with study protocols, regulatory standards, and Good Clinical Practice (GCP) guidelines.
• Foster strong relationships with investigators and site staff to achieve enrollment targets and maintain continuous engagement with sites.
• Monitor study performance metrics, proactively address potential risks or operational issues, and implement appropriate mitigation strategies.
• Ensure compliance with relevant regulatory frameworks, including FDA regulations and ICH-GCP standards, throughout the clinical trial lifecycle.
• Oversee vendor interactions and collaboration with external partners such as CROs, laboratories, and imaging facilities.
• Assist in drafting and reviewing essential study documents including protocols, informed consent forms, case report forms (CRFs), and operational procedures.
• Create study processes and materials that enable consistent execution and adherence to administrative standards.
• Maintain oversight of study documentation, which includes managing the sponsor Trial Master File and conducting 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.
• Proven track record in Clinical Operations; experience in oncology clinical trials is highly preferred.
• Strong understanding of global clinical research regulations and industry standards, including ICH-GCP and FDA guidelines.
• Experience in managing trials through the entire study lifecycle from start-up to closeout.
• Demonstrated project management skills, including timeline planning, prioritization, and resource coordination.
• Excellent communication and stakeholder management abilities across cross-functional and international teams.
• Analytical mindset with the capacity to foresee and address operational challenges.
• Familiarity with clinical trial management platforms such as Veeva CTMS or similar systems.
• Knowledge of oncology indications, treatment methods, and clinical terminology.
• Able to work onsite a minimum of three days per week.