Note: The job is a remote job and is open to candidates in USA. Arcus Biosciences is seeking a Clinical Trial Manager to support clinical studies in a matrix environment. The role manages operational aspects of clinical trials, including site and vendor oversight, monitoring activities, data review, study documentation, timelines, budgets, and cross-functional communications.
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
- Obtains and reviews all required essential documents necessary for study/site initiation
- Maintains/files accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
- Manages and tracks patient enrollment, site performance and monitoring metrics
- Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies
- Supports the development and review of clinical study plans, presentations or study-related documents
- Supports the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems
- Assists 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
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed
- Works closely with data management lead to perform data cleaning activities with cross-functional team
- May lead and coordinate protocol deviation review and documentation
- Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (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
- Reviews monitoring trip reports and track resolution of all action items
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
- Assists with providing oversight of CROs and vendors
- Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues
- Assists with set-up and review of clinical TMF
- Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
- Contributes 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 applicable
- Recommends and implements innovative ideas to increase efficiency and quality of program management activities
- Contributes to process and departmental and cross-functional improvement activities
Skills
- * 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 Federation Regulations
- * Understanding of clinical trial processes from study start-up through study closure
- * Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) 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 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)
- 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
- This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based
Benefits
- Remote or in-house work arrangement, depending on prior experience
- Bay Area staff will operate in a hybrid or office-based model aligned with Arcus expectations
- Opportunity to participate in stock programs
- Performance-based bonus
- Comprehensive benefits package
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