Senior Clinical Trial Manager Associate Clinical Operations

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Trial Management Associate, Clinical Operations based in the United States.** This is a clinical operations opportunity supporting the successful execution of clinical studies within a fast-paced biotechnology environment focused on innovative oncology therapies. You’ll take an active role in planning and managing key clinical vendors, ensuring deliverables remain on schedule, within budget, and compliant with applicable standards. The role provides broad exposure to clinical study execution, including CRO collaboration, country and site start-up, documentation, risk management, and operational planning. You’ll work closely with cross-functional study teams and external partners to identify issues early, monitor performance, and drive timely resolution. Strong attention to detail and proactive communication will be essential to maintaining high-quality study execution and reliable clinical documentation. You’ll also contribute to process improvement and leverage AI tools to enhance productivity, quality, and operational effectiveness. This fully remote U.S. role is well suited to a clinical operations professional who thrives in collaborative, dynamic environments and wants to contribute to meaningful patient-focused research. ### Accountabilities: - Manage clinical study vendors, including central laboratories, RTSM/IRT, imaging, dosimetry, and other specialized providers, ensuring deliverables are completed on time, within budget, and in accordance with SOPs, FDA requirements, and ICH/GCP guidelines. - Participate actively in vendor meetings, contribute to operational planning, develop and monitor risk mitigation strategies, and review key performance indicators and other vendor performance metrics. - Support the Study Lead with CRO management, including reviewing clinical study protocols, informed consent forms, study plans, and other essential clinical documentation. - Participate in CRO and Study Execution Team meetings and contribute to operational strategy, including study and country start-up activities. - Support site management activities such as site feasibility assessments, site selection and initiation, issue resolution, and coordination with relevant internal and external stakeholders. - Track and maintain study documentation, ensuring Trial Master File completeness, accuracy, and overall quality. - Monitor vendor progress and performance, proactively identify operational risks and issues, and escalate significant concerns to appropriate internal stakeholders to support timely resolution. - Support the management of vendor budgets and invoicing processes in accordance with study contracts and agreed financial requirements. - Analyze and summarize vendor performance information, identify emerging study risks, and communicate relevant findings to the Study Lead and broader study team. - Use AI-enabled tools appropriately to improve individual productivity, analytical efficiency, and quality of clinical operations work. - Support additional clinical operations activities and improvement initiatives as required, with up to 10% travel expected. ### Requirements - 2–3+ years of clinical operations experience within the biotechnology, pharmaceutical, CRO, or related clinical research environment. - Bachelor’s degree in a scientific, healthcare, life sciences, or related discipline is preferred. - Experience managing or coordinating external clinical vendors, with an understanding of vendor deliverables, timelines, performance metrics, issue management, and operational risk. - Familiarity with clinical trial execution, CRO collaboration, site start-up, study documentation, and clinical research processes. - Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA requirements, and applicable clinical research regulations. - Strong organizational skills and exceptional attention to detail, with a consistent focus on quality, accuracy, and timely execution. - Proactive and independent working style, with the ability to communicate frequently and effectively and take ownership of assigned responsibilities. - Strong problem-solving skills and the ability to assess operational challenges, identify risks, and support practical solutions in a dynamic environment. - Ability to collaborate effectively with cross-functional teams and build productive relationships with internal stakeholders and external partners. - Comfortable working in an environment with changing priorities, high levels of flexibility, and multiple concurrent operational requirements. - Experience with Microsoft Project and Smartsheet is desirable. - Familiarity with AI tools and a willingness to use emerging technologies to improve productivity and quality is advantageous. ### Benefits - Fully remote position within the United States. - Full-time employment with a base salary range of **$119,116–$144,341**, depending on factors such as experience, skills, work location, and applicable compensation requirements. - Eligibility for additional discretionary incentive compensation and stock opportunities. - Comprehensive benefits that may include medical, dental, vision, life, and disability insurance. - Retirement and financial protection benefits. - Flexible Time Off for eligible U.S.-based exempt employees, with no fixed accrual limit subject to manager approval. - 11 paid company holidays annually. - Additional time-off programs may include paid sick leave, paid volunteer days, summer-hours flexibility, and leave options for medical, parental, caregiver, bereavement, military, and other qualifying needs. - Annual global shutdown period between Christmas Day and New Year’s Day for eligible employees. - Opportunities to work on innovative clinical research and contribute to the development of therapies addressing serious diseases. - Collaborative, multidisciplinary environment with exposure to clinical vendors, CROs, study teams, and cross-functional stakeholders. - Opportunities to use AI-enabled tools and modern approaches to improve clinical operations productivity and quality. - Workplace accommodations and support are available for qualified individuals with disabilities throughout the recruitment and employment process.