Clinical Trial Manager - Contractor

Overview 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. Responsibilities Day-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. Obtain and review all required essential documents necessary for study/site initiation Maintain/submit accurate and timely sponsor/site correspondence and communication. Prepare and present project progress reports Manage and track patient enrollment, site performance and monitoring metrics Perform tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies Support the development and review of clinical study plans, presentations or study-related documents Support in the development and design of CRFs, including participating in the EDC and IxRS specification process and UAT on related systems Assist 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 sites Perform in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed Work closely with data management lead to perform data cleaning activities with cross-functional team May lead and coordinate protocol deviation review and documentation Manage clinical monitoring activities and the overall site management ensuring compliance with GCP and applicable regulations and tracking of site performance metrics May 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 in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as required Review monitoring trip reports and track resolution of all action items Participate in the selection, training, and evaluation of study personnel (vendor, CRO, internal) Assist with providing oversight of CROs and vendors Coordinate with CRO and SMTL in clinical site oversight, data entry timeliness, and assist with resolving site issues Assist with set-up and review of clinical TMF Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings, as requested Contribute to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc. Provide 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 applicable Recommend and implement innovative ideas to increase efficiency and quality of program management activities Contribute to process and departmental and cross-functional improvement activities Qualifications Bachelor’s degree, preferably in a scientific field 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology Demonstrates core understanding of clinical trial related terminology and activities Thorough understanding of ICH GCP guidelines and Code of Federal Regulations Understanding of clinical trial processes from study start-up through study closure Ability to establish priorities, sense of urgency and collaborate with the study team, cross functional team members and external partners/vendors Excellent planning and organization skills Self-motivated, assertive, and able to function independently and as part of a team Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners) Excellent IT skills and experience using clinical trial management systems (e.g., EDC, IRT, CTMS, eTMF, etc.) Ability and willingness to travel 10-20% (domestic and international) #LI-Remote #LI-JS1 #J-18808-Ljbffr