The Senior Clinical Data Manager provides clinical data expertise to project teams in a fully outsourced Clinical Data Management model. The successful candidate will have good knowledge of the end-to-end clinical research and Clinical Data Management processes, as well as global regulatory, and industry rules and guidances (i.e. ICH, GCP) to support drug or biologics development processes and global project submissions through to approval. This role is responsible for managing data management components of projects and vendor performance. The incumbent may contribute to department initiatives and non-study projects.

Responsibilities

• May oversee or manage Data Management service providers (e.g., EDC vendor, labs, imaging vendors, CRO/FSP) to ensure agreed upon performance on quality and timeliness of deliverables.
• Lead or support data management study start-up activities, including development and review of eCRF requirements, EDC database specifications, eCRF Completion Guidelines, Data Management Plans, Data Validation Specifications and User Acceptance Testing
• Oversee the development and maintenance of data transfer agreements with external data vendors (e.g., clinical laboratories, imaging vendors, etc) and external data reconciliations.
• Responsible for ensuring data collected in the clinical database and by vendors meet the requirements of the study objective and quality standards. Manage the Arcus Clinical Data Review process, including the data query process for inconsistencies, omissions, or errors. May issue data queries in EDC.
• Represent data management on cross-functional teams, providing accurate study status updates, timeline, and proactive communication of data management deliverables and potential risks and mitigations
• May provide input to study teams on study documents (e.g., Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, etc.)
• Contribute to the identification and selection of data management vendors through due diligence and proper vetting of vendor proposals.
• May review, and revise SOPs, guidelines, Work Instructions, and templates
• Maintain all data management internal files, ensuring preparedness for regulatory inspections.

Knowledge, Skills, and Abilities Required

• Bachelor's Degree or higher with 4+ years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines
• Proven track record of on-time and high-quality Data Management deliverables
• Oncology experience preferred
• Highly organized, outcome oriented and self-motivated performance
• Ability to adapt to change in a fast-paced work and growth environment
• Experience with multiple EDC systems, although Medidata products preferred, through full development life cycle. (Medidata modules of interest, Rave EDC, Rave RTSM, Rave Safety Gateway, Rave Imaging, Coder, Lab Management Module; some core configuration and URL management knowledge desirable)
• General knowledge of industry standards and best practices such as CDISC/CDASH
• Knowledge of and experience with MedDRA and WHO Drug data dictionaries
• Familiarity with handling lab/image data from external data sources
• Skill and knowledge in data review listings and metrics reporting
• Attention to detail and the ability to work independently or with oversight, within a multi-disciplinary team, as well as with external partners and vendors
• Good communication skills and positive interactions with colleagues
• Ability to effectively manage a variety of data management tasks for one or more clinical studies at different stages of activity
• Able to travel as needed; less than 25% travel required.

This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $135,000 - $145,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. 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/.

Arcus Biosciences, Inc. is an Equal Opportunity Employer.

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