Clinical Trial Manager

Clinical Trial ManagerThe 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 in accordance with ICH GCP, regulations, the protocol, and company SOPs/PoliciesSupports the development and review of clinical study plans, presentations or study-related documentsSupports the development and design of CRFs, including participating in the EDC and IXR 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 documentationManages 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 in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as requiredReviews monitoring trip reports and track resolution of all action itemsParticipates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)Assists with providing oversight of CROs and vendorsCoordinates with CRO and SMTL in clinical site oversight, data 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 applicableRecommends and implements 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 in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncologyDemonstrates core understanding of clinical trial related terminology and activitiesSkills/AbilitiesThorough 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)This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $120,000 - $135,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.EOE Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/VetsPhysical Requirements Office Setting Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.