Arcus Biosciences

Engineer

• Process and QC high-dimensional datasets to expand internal databases
• Maintain and improve internal pipelines for data processing
• Develop standardized internal pipelines for processing of additional data types
• Work closely with Bioinformatics Scientists on improving internal processes and databases
• Collaborate with constituencies in IT and Scientific Computing to improve infrastructure
• Serve as the technical resource for optimizing pipelines and developing reproducible frameworks

Bioinformatics Engineer

Manager

• Oversees site contracts, grants and payments to full-service CRO partnerships
• Responsible for operational execution of budgets, payments, reconciliation, and study financial controls
• Maintains just-in-time CRO funding, and supports accruals, reconciliation, and inspection-readiness
• Accountable for oversight and ongoing management, assessment and reconciliation of study-level contracts and grants
• Establish and maintain policies for invoiceables, pass-throughs, conditional procedures, screen-fail handling, and complex visit structures
• Develop and maintain SOPs/WIs governing budgeting, payments, documentation and global transparency requirements
• Understand global study budget forecasts, partnering closely with Clinical Operations and Finance
• Implement and monitor just-in-time CRO funding, minimizing idle cash at CROs while ensuring on-time site payments

Senior Manager, Clinical Trial Payments – Contractor

Operations

• Expertly advise on and deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
• Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.
• Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical trial samples, including oversight of sample collection at sites, shipment to vendor for processing/testing, sample queries and final sample disposition.
• Be the primary point of contact for study team related to sample operations for assigned clinical trials.
• Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
• Track and report on sample management status and address issues proactively.
• Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.
• Mentor junior Biosample Managers and Biosample Specialists.

Senior Manager, Biosample Operations

QA Engineer

• Responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines
• Participate in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures
• Support the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas
• Provide expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies
• Include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors
• Lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP)
• Support clinical study teams as a core team member for assigned studies through attendance at study management team meetings, review of study documents, and QA consultation on GCP - related questions
• Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership, including the assessment of serious breaches
• Maintain a high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct
• Collaborate with CRO quality counterparts as delegated, including participation in QA-QA meetings
• Participate in internal and external GCP audits as assigned in support of the execution of the audit programs and support the management of audit lifecycle activities as assigned, such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and audit closing
• Maintain up to date audit execution results in Arcus electronic quality management system (Veeva Quality Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity
• Clearly present audit findings and/or other related audit information to appropriate departmental personnel, as required
• Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
• Support Quality Assurance activities during partner audits and/or regulatory inspections, as assigned
• Participate in inspection readiness and pre-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned
• Support strategic organizational quality and compliance process improvement initiatives
• Support Investigator Site Audits

Senior Manager, CQA

• Provide operational support for the Arcus IST (Investigator-Sponsored Trial) program including interfacing with external investigators
• Oversee study specific timelines and manage appropriately

Bioinformatics Engineer

Senior Manager, Clinical Trial Payments – Contractor

Senior Manager, Biosample Operations

Senior Manager, CQA

Senior Manager, Medical Affairs – IST Operations