The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or in-house, depending on prior experience. This position will report to a Clinical Operations Manager. Bay Area staff will operate in a hybrid or office based model aligned with Arcus expectations.ResponsibilitiesDay-to-day management of assigned operational aspects of low to medium complex clinical trials, including but not limited to vendor/ laboratory management, oversight of clinical sites, etc.Obtains and reviews all required essential documents necessary for study/site initiationMaintains/files accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reportsManages and tracks patient enrollment, site performance and monitoring metricsPerforms tasks ulations, the protocol, and company SOPs/PoliciesSupports the development and review of clinical study plans, presentations or study-related documentsSupport luding participating in the EDC and IXRS specification process and UAT on related systemsAssists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sitesPerforms in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as neededWorks closely with data management lead to perform data cleaning activities with cross-functional teamMay lead and coordinate protocol deviation review and documentationManage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metricsMay perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files ulatory requirements, site and CRO SOPs, and study plans, as requiredReviews monitoring trip reports and track resolution of all action itemsParticipates ining, and evaluation of study personnel (vendor, CRO, internal)Assists with providing oversight of CROs and vendorsCoordinates with CRO and SMTL a entry timeliness, assists with resolving site issuesAssists with set-up and review of clinical TMFOrganizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requestedContributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicableRecommend and implement innovative ideas to increase efficiency and quality of program management activitiesContributes to process and departmental and cross-functional improvement activitiesQualificationsBachelor’s degree, preferably in a scientific field5+ years of related industry experience s 2+ years of trial management experience, preferably in oncologyDemonstrates core understanding of clinical trial related terminology and activitiesThorough understanding of ICH GCP guidelines and Code of Federation RegulationsUnderstanding of clinical trial processes from study start-up through study closureAbility to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendorsExcellent planning and organization skillsSelf-motivated, assertive, and able to function independently and as part of a teamStrong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)Ability and willingness to travel 10-20% (domestic and international)
3 months ago