Associate Director, Clinical Data Management (Office OR Remote)

at  Arcus Biosciences

The Associate Director, Clinical Data Management provides leadership and clinical data expertise to project teams in an outsourced or insourced Clinical Data Management model. The successful candidate has advanced knowledge of clinical research, Clinical Data Management, and regulatory and industry guidance. This role is responsible for managing all Clinical Data Management components of projects assigned, including vendor performance for outsourced studies. This position will mentor Clinical Data Management team members and will direct activities of Arcus Clinical Data Management staff and vendors. The incumbent may contribute to department initiatives and non-study projects.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

• Bachelor’s Degree or commensurate experience with 10+ years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center
• Ability to train, mentor, and oversee Data Managers and their deliverables, as well as with external partners and vendors
• Applied 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
• Ability to adapt to change in a fast-paced work and growth environment
• Experience with EDC systems through full development life cycle. Medidata products strongly preferred, including iMedidata Cloud User and Site Administration, Core Configuration awareness, Rave Coder, Rave Lab Administration and Lab Loader, Architect, Rave EDC, Rave Reporter, and customizable listing tools like Business Objects or JReview
• Applicable knowledge of industry standards and best practices such as CDISC/CDASH
• Knowledge of and experience with MedDRA and WHO Drug data dictionaries
• Familiarity with collection and reconciliation of data from external data sources
• Skill and knowledge in data review listings, metrics reporting, and standards development
• Attention to detail and the ability to work independently and proactively
• Excellent verbal and written communication skills, including a positive disposition with
• Strong ability in interpersonal collaboration with colleagues
• Successful communication skills with technical concepts to cross functional groups for awareness and understanding, as well as reporting status updates within the Arcus Data Management, Biometrics, and Clinical Development departments
• Minimal to no travel required
  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 $185,000- $195,000 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.

• Primary owner and main point of contact for all Clinical Data Management activities for assigned studies and projects.
• Oversee Data Management internal team and external vendors for assigned studies and projects, including assessment and management of quality and efficiency to ensure milestones are delivered to quality expectations, on time, and on budget. This includes delegating tasks to team members while verifying completion and quality of work. May include DM vendor selection and management when assigned studies are outsourced to a DM CRO vendor.
• Direct and perform study start-up activities, including clinical protocol review, budget creation, timeline creation, risk management, CRF and edit check specifications and user acceptance testing, CRF Completion Guidelines, Offline Listing Specifications, and Data Management Plans.
• Direct and perform study conduct activities, including budget management, local lab normal range collection and entry, metric development and reporting, offline listing data review, cross functional query management, vendor data reconciliation, SAE reconciliation, perform medical coding and facilitate cross functional review, database migrations, data handling plans, and interim deliverables.
• Direct and perform study close-out activities, including timeline creation and risk management, as well as leading the cross functional study management team to successfully complete all pre and post lock requirements.
• Collaborate with internal and external database programming team members through study start-up database creation, conduct database migrations, and close-out database lock activities.
• Collaborate with Clinical Programming on the development, quality control, and maintenance of all programmed metrics, reports, and listings, including Data Transfer Agreements to facilitate vendor data reconciliation listings.
• Responsible for ensuring data collected in the clinical database and by vendors meets the requirements of the study objectives and quality standards.
• Manage the cross functional Arcus Clinical Data Review process, including primary ownership of overall data health of a study, DM data cleaning, metric reporting, cross-functional query management, and leading data health meetings. This also includes conducting quality review of data cleaning to assess adherence to study requirements.
• Contribute Data Management expertise to cross-functional study teams, providing study status updates, timelines, risk assessment and mitigation plans, and proactive communication.
• Provide input on study documents such as Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, and Safety Monitoring Plans.
• Collaborate with Data Management Leadership to develop, review, and revise SOPs, Work Instructions, and templates.
• Maintain all Data Management documentation with proper filing into the electronic Trial Master File, ensuring preparedness for regulatory inspections.