The Clinical Study Manager is responsible for the day-to-day management of multiple sponsored and ISS (investigator-initiated) clinical trials.
They help manage the CRO team, clinical vendors, clinical monitors, and clinical trial sites.
The Clinical Study Manager works closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and compliant with ICH/GCP regulatory guidelines, company goals, and budgets.
They should be a capable manager able to perform and manage all the necessary duties and functions necessary to deliver a quality study on time and within budget.Primary Job FunctionsProvides expertise and oversight of CROs as well as investigator-initiated sites managing clinical studiesOversees site start-up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files (TMF), and data clean up, as applicable for each studyParticipation in eCRF design, project plans, and overall studies’ dashboardsProactively identifies potential study issues/risks and recommends/implements solutionsParticipates in and facilitates the vendor selection process for outsourced activities, including the request for proposal (RFP) processManage study-related activities including timelines, study visits, site selection, site initiation, site management, study drug management, site payments, and closeout activities with various CROs and site staff for investigator managed studiesDevelops and reviews various study documents for GCP compliance (DMP, SMP, CMP, etc.)Responsible for managing site and vendor budget activitiesContributes to projects in various capacities to support broader organizational goalsPerform on-site monitoring, audit, and verify data entered on eCRFs are complete, accurate, and consistent with source data.
Generate Monitoring Vist Reports (MVR) after each visit.Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred)8+ years study management experience in clinical and drug developmentExperience in managing CROs, specialty labs, and outside vendorsExperience in study start-up, data cleaning, and closeoutExtensive experience in planning, risk mitigation, trial budgets, site selection, clinical supplies management, bio sample management, conduct and monitoring of clinical studiesExperience overseeing and managing a Trial Master File Demonstrated experience in oncology, CV, or other therapeutic areasExperience performing on-site clinical site monitoring visitsWorking knowledge of ICH GCP guidelinesAttention to detail with strong analytical and problem-solving skillsExcellent planning and organizational skillsHigh level of initiative and ability to work independentlyExcellent written and verbal communication skillsPossess excellent interpersonal skillsProficiency with MS Word, Excel, Outlook, Project, and PowerPointOTHER REQUIREMENTS This role is work-from-home with travel to Los Angeles (twice per quarter; 3-5 days duration)#LI-Remote