Clinical Systems Manager, Clinical Operations (Office OR Remote)

Clinical Systems Manager, Clinical Operations will play a pivotal role in the Business Operations, Clinical Operations Organization supporting the implementation and management of clinical trial systems, including Veeva Vault Clinical (Clinical Trial Management System (CTMS) and Trial Master File (TMF)), and Veeva Vault Study Training (Learning Management System (LMS)), and any future product, implementation, or integration.  They will work closely with cross-functional teams to manage/ support / assist in the successful deployment, integration, training, accesses, and operation of these systems to enhance clinical trial efficiency and ensure participant safety.   This position is remote, or if located in San Francisco Bay area hybrid.  This position will report to the Head of Business Operations, Clinical Operation.    Responsibilities:

• Management of Clinical Operations processes and systems, such as Learning Management System LMS, CTMS, TMF, etc. 
• Support the selection, configuration, customization, testing, implementation, integration, and training of new clinical systems to ensure they meet business needs. 
• Assist with set-up, maintenance, and closeout of clinical systems, if applicable, and work with the CRO or vendor to audit and resolve discrepancies. 
• Assist with analysist of business process to identify opportunities for optimization and improvement.  Provide support to address existing and potential gaps in clinical systems. 
• Participate and support Clinical Operations in activities related to audits and inspections.  Respond and assist in relevant CAPA/ Process Improvements, resulting from audit and/ or inspection 
• Support inspection readiness. 
• Provide technical support and guidance to ensure effective system utilization.  Provide ongoing support and troubleshooting for clinical systems. 
• Track and prepare study-specific information utilizing databases, trackers, and other study tools.   
• Clean existing organizational and personnel records, including removing duplicates, inactivating irrelevant data, standardizing nomenclature, fix errors, handle missing values, clear formatting, etc.
• Quality check existing records
• Escalate potential issues or risks
• Work with multi-functional team to problem solve issues
• Work with study teams to ensure current site and personnel are appropriately documented

 Qualifications:

• Bachelor’s degree, preferably in a scientific field
• Minimum 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  
• Minimum 2+ years of relevant experience, including study management or systems experience  
• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
• Strong organization, analytical, problem solving, and decision-making skills. 
• High attention to detail and accuracy in data handling & documentation.
• Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management)
• Understanding of clinical trials, clinical trial systems, regulatory requirements and industry standards for clinical trials (e.g., ICH GCP and GDocP) 
• Experience and competency in Microsoft applications and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.).   Preference given to experience with various Veeva Vault applications. 
• Excellent interpersonal communication
• Self-motivated and able to work independently or as part of a team.

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 $150,000 - $160,000 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. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. EOEArcus 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