Clinical Trial Manager, Oncology, (Bilingual Asian)

Clinical Trial Manager, Oncology, (Bilingual Asian) Northern New Jersey or San Francisco area CA Position Summary We are seeking an experienced Clinical Trial Manager to lead the operational execution of global oncology clinical studies within a fast-paced, research-driven biotechnology organization. This individual will be responsible for overseeing all aspects of study conduct, ensuring compliance with applicable regulations, maintaining study timelines and budgets, and driving the delivery of high-quality clinical data. This role requires fluency in English and at least one of the following languages: Mandarin, Cantonese, Japanese, or Korean . Candidates should possess strong written and verbal communication skills and be comfortable collaborating with international teams and external stakeholders. Daily Responsibilities Lead and oversee the operational execution of global oncology clinical trials from study start-up through closeout. Develop and implement study management plans, timelines, and operational strategies to ensure successful trial delivery. Partner with cross-functional teams including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and external partners to support study objectives. Manage study start-up activities including site identification, feasibility assessments, site selection, and essential document collection. Support site activation, training, enrollment, and ongoing study conduct to ensure protocol compliance and data quality. Build and maintain productive relationships with investigators, study coordinators, and site personnel to support patient recruitment and retention. Monitor study progress and proactively identify operational risks, issues, and mitigation strategies. Ensure compliance with ICH-GCP, FDA regulations, and other applicable global regulatory requirements. Oversee external vendors and service providers, including CROs, laboratories, imaging vendors, and specialty service providers, ensuring quality deliverables and adherence to timelines. Contribute to the review and development of clinical study documents, including protocols, informed consent forms, case report forms, study plans, and related operational documentation. Maintain inspection-ready study documentation and support Trial Master File oversight throughout the study lifecycle. Participate in process improvement initiatives that enhance clinical trial efficiency, quality, and execution. Required Bachelor's degree with 7+ years of relevant experience or Master's degree with 5+ years. Strong clinical operations experience within the biotechnology, pharmaceutical, or clinical research industry. Oncology clinical trial experience strongly preferred. Demonstrated success managing clinical trials across multiple regions and countries. Thorough understanding of ICH-GCP guidelines, FDA regulations, and global clinical trial requirements. Experience managing study timelines, budgets, resources, and vendor relationships. Excellent project management, organizational, and problem-solving skills. Strong interpersonal skills with the ability to influence and collaborate across diverse teams and stakeholders. Familiarity with clinical trial management systems, electronic trial master files, and clinical technology platforms. Knowledge of oncology drug development, treatment approaches, and clinical research practices preferred. Location This position follows a hybrid work model, requiring onsite presence three days per week at one of the organization's U.S. operational hubs. Position pays excellent base salary plus bonus and stock. #J-18808-Ljbffr Clark Davis Associates