The Business Operations Specialist is responsible for enabling clinical trial execution through a combination of supporting implementation and management of clinical trial systems (CTMS, Learning Management System (LMS), TMF, etc.) and clinical records management. This role ensures clinical systems and TMF activities are executed in compliance with Good Clinical Practice (GCP), ICH E6 guidelines, applicable regulatory requirements (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trial Directives), and Arcus SOPs. They work closely with cross-functional teams to support and assist operation of these systems to enhance clinical trial efficiency and utilize effectively as well as ensures TMF remains current, accurate, and inspection ready throughout the trial lifecycle.ResponsibilitiesClinical Systems Management
Support the support the selection, implementation, configuration, testing, maintenance, training, and closeout of clinical trial systems, including CTMS, eTMF, LMS, and related platforms.
Provide day-to-day system support, troubleshooting, and guidance to study teams to ensure effective and compliant system use.
Assist with user access management, training coordination, system integrations, and vendor/CRO oversight activities.
Perform data entry, reconciliation, and quality checks across clinical systems and tracking tools.
Maintain study, site, and personnel records, including data cleaning, standardization, and error resolution.
Develop and maintain metrics, dashboards, and reports to support operational oversight.
Analyze clinical business processes to identify gaps and opportunities for optimization and process improvement.Provide support to address existing and potential gaps in clinical systems.
Escalate system, data, or process risks and work cross functionally to resolve issues
Participate in and support activities related to audits, inspections, and inspection readiness/ preparedness.
Clinical Records (TMF) Management
Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
Review and classify documents collected from internal and external sources
Reconcile essential documents to avoid duplication
Support study teams with the TMF quality review process
Perform QC and maintenance of eTMF for assigned studies
Perform data entry and reconciliation in various clinical systems and tracking tools
Provide input on revision of TMF related Work Instructions and SOPs
Support the management and oversight of the CRO study-specific trial master files
Support the coordination of the transfer of study-specific trial master files from the CRO
Follow up on quality findings
Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing.
Participation in audit, inspection readiness preparation and inspection activities as needed
Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF
May provide training and mentoring activities for new and current staff
Develop metrics, reports, and TMF tools/trainings
Act as stand-in leading team meetings, managing team tasks as needed
Qualifications
Bachelor’s or Associates degree (preferably in a scientific or related field) and 5+ years of experience in clinical operations, TMF management, clinical systems, or related roles within the pharmaceutical or biotechnology industry.
Strong understanding of clinical trials, clinical trial processes and TMF requirements, including ICHGCP, GDP, and regulatory expectations.
Familiarity with the DIA TMF Reference Model and industry best practices.
Strong organizational, analytical, and problem-solving skills with high attention to detail.
Ability to manage multiple priorities in a fast paced, high-volume environment.
Strong communication and interpersonal skills; ability to collaborate effectively across functions and with external partners.
Proficiency with Microsoft Office and clinical trial management systems.
Team oriented, flexible, and able to work independently while maintaining integrity and high ethical standards.
Position may require occasional travel
Physical 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.
This role can be based at our Hayward, CA or Brisbane, CA location (preferred) or can be remote based. Arcus Biosciences is an equal opportunity employer.#LI-JS1#LI-Remote
