Clinical Trial Manager (Brisbane, CA)

Job Description

Summary and Scope: We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) to contribute to the operational execution of a global, pivotal clinical trial. The successful candidate will be a key member of the clinical operations team and will be responsible for overseeing various aspects of the trial from startup through closeout, ensuring adherence to timelines, budget, quality standards, and regulatory requirements.Guiding Principles: The below principles drive all that we do here at Client. We are looking for like-minded individuals who feel passionately about these same principles to join our team. Develop meaningful therapies for patients Value diversity in building teams Commit to growth and collaboration Work with integrity and rigor Embrace the energy that drives a successful biotech Responsibilities (not limited to the below and may evolve over time and change depending on business needs and individual expertise):Trial Management: Contribute to the planning, implementation, and execution of a global, pivotal clinical trial. Develop and manage study timelines, budget, and resources. Oversee the selection, contracting, and management of CROs, vendors, and investigative sites, and ensures that performance expectations are met. Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines). Ensure compliance with GCP, ICH guidelines, and all applicable regulations. Proactively identify and mitigate potential risks to trial execution. Site Management: Support site selection, qualification, initiation, and monitoring activities. Ensure timely enrollment and data collection at clinical trial sites. Address and resolve site-related issues effectively. Communication and Collaboration: Foster effective communication and collaboration within the study team and with external stakeholders. Provide regular updates on trial progress to senior management. Lead cross-functional and clinical operations team meetings. Contribute to the preparation of study reports, presentations, and publications. Vendor Management: Oversee the performance of CROs and other vendors involved in the trial. Ensure vendor compliance with contractual obligations and quality standards. Data Management: Collaborate with the data management team to ensure data integrity and timely database lock. Review and analyze clinical trial data to identify trends and potential issues. Regulatory Compliance: Maintain accurate and complete trial documentation. Contribute to the preparation of regulatory submissions (e.g., IND, CTA). Ensure compliance with all applicable regulations and guidelines. Education, Experience & Qualifications: Bachelor's degree in a life sciences discipline; advanced degree (e.g., MS, PhD) preferred. Experience: CTM - Minimum of 5-7 years of experience in clinical trial management, with at least 1 year in oncology and 2 years as a study manager. OR Sr. CTM - Minimum of 7-9 years of experience in clinical trial management, with at least 2 years in oncology and 4 years as a study manager. Strong understanding of clinical trial methodology, GCP, ICH guidelines, and relevant regulations. Experience with all phases of clinical trial execution, from startup to closeout. Excellent project management, organizational, and communication skills. Must be able to develop and present varied and unique ideas. Proven ability to work independently and as part of a team. Experience in liver cancer or other solid tumor indications is highly desirable. Ability to travel up to 15% of the time. #J-18808-Ljbffr