Job Opportunities API

Study Monitoring Lead Department: Global Clinical Operations Position Summary The Study Monitoring Lead is responsible for the operational oversight of global clinical trials, ensuring studies are executed in accordance with protocol, timelines, ICH-GCP, regulatory requirements, and company SOPs. The SML oversees study feasibility, site management, monitoring activities, and CRO/vendor performance while partnering with cross-functional teams to drive successful study execution. Responsibilities Lead study feasibility activities, evaluating country and site capabilities, patient access, and operational readiness. Partner with the Clinical Study Manager, Clinical Study Physician, and CROs to support country and site selection. Oversee site activation activities, including regulatory documentation, contracts, investigational product supply, laboratory kits, and other start-up requirements. Monitor site activation, enrollment, protocol compliance, and data quality. Prepare, review, or approve Monitoring Plans, Laboratory Manuals, patient-facing materials, and other operational study documents. Oversee CRO and vendor performance related to site management and monitoring. Support training for CRO Clinical Trial Leads, CRAs, and investigative sites. Oversee remote and on-site monitoring activities, ensuring timely visit completion, issue resolution, and follow-up. Conduct sponsor co-monitoring visits and perform monitoring or co-monitoring activities as needed. Track study metrics, including site activation, enrollment, monitoring visits, protocol deviations, and overall study progress. Oversee biological sample tracking and investigational product management with study stakeholders. Collaborate with Clinical Operations, Data Management, Medical, Safety, Regulatory, Clinical Supply, CROs, vendors, investigators, and study sites to ensure efficient study execution. Identify and resolve operational risks, escalating issues when appropriate. Ensure compliance with study protocols, ICH-GCP, regulatory requirements, and company SOPs while supporting inspection readiness. Qualifications Master's degree in Life Sciences or a related field. 5+ years of clinical operations experience, including 3+ years monitoring oncology studies as a CRA or comparable site management role. Experience with study feasibility, site selection, site activation, monitoring oversight, and CRO/vendor management. Strong knowledge of ICH-GCP, global clinical trial regulations, and inspection readiness. Excellent communication, collaboration, organizational, analytical, and problem-solving skills. Ability to travel internationally as required.