Clinical Trial Manager/Sr Clinical Trial Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager/Sr Clinical Trial Manager based in the United States. The Clinical Trial Manager/Senior Clinical Trial Manager will oversee the planning, execution, and management of global oncology clinical trials from study start-up through close-out, supporting clinical development across Phases 1–3. This role combines strategic coordination with hands-on trial management to ensure studies meet scientific, operational, regulatory, and quality standards. You will collaborate with investigators, clinical research organizations (CROs), and specialized vendors to support effective study delivery. The position involves coordinating budgets, contracts, timelines, site activation, patient enrollment, and clinical trial materials. Working closely with cross-functional teams, you will contribute to study documentation, data quality, and ongoing process improvements. This opportunity suits an experienced clinical operations professional who thrives in a fast-paced, collaborative environment and is motivated by advancing oncology research and improving outcomes for patients. Accountabilities - Manage global Phase 1–3 oncology clinical trials in alignment with clinical development plans, ICH-GCP guidelines, and applicable FDA and international regulatory requirements. - Identify and recruit study sites globally, build relationships with investigators, and support site selection, qualification, and activation. - Develop requests for proposals (RFPs), participate in vendor selection, and assist with negotiating vendor contracts and clinical trial agreements. - Oversee CROs and other study vendors, including interactive response technology (IRT), laboratories, and central ECG and imaging providers. - Track trial progress, patient enrollment, clinical trial material inventory, biological samples, timelines, budgets, accruals, and financial projections.

- Review monitoring visit reports for completeness and adherence to documentation requirements, and support study monitoring and quality oversight. - Coordinate the packaging, labeling, and distribution of clinical trial materials. - Contribute to the development and review of protocols, informed consent forms, IRB/EC submissions, clinical SOPs, and other essential trial documentation. - Prepare, review, and approve study materials, including case report forms (CRFs), patient diaries, drug accountability forms, investigator and study manuals, project plans, and monitoring reports. - Support electronic case report form design, IRT development, data cleaning, and the creation of appropriate data outputs. - Communicate study progress, risks, and operational updates to management and program teams. - Collaborate with cross-functional departments, including Finance and Research, to support broader development objectives. - Provide leadership, guidance, and mentorship to clinical team members, including Clinical Research Associates (CRAs). - Perform responsibilities in accordance with organizational policies, core values, and applicable regulatory requirements. Requirements: - An undergraduate degree in life sciences or a related health profession, such as pharmacy, medicine, nursing, or allied health sciences, is preferred. - Clinical Trial Manager: At least 5 years of relevant oncology clinical operations experience within a pharmaceutical company or CRO, including trial set-up, monitoring, and close-out for US and international Phase 1–3 studies conducted before NDA submission. - Senior Clinical Trial Manager: At least 7 years of relevant oncology clinical operations experience, including trial set-up, monitoring, and close-out across US and international Phase 1–3 studies conducted before NDA submission.