Description
The Associate Director, Clinical Data Systems will participate in developing the Data Management Technology Team (DM Tech Team) strategy and lead activities while interfacing with the Clinical Data Management (CDM) team and stakeholders to ensure that DM Tech Team services are delivered in a high-quality manner. The successful candidate will have good knowledge of clinical data management systems, as well as global regulatory and industry rules and guidance (i.e., ICH, GCP). This role is responsible for overseeing Clinical Data Systems administration. This position will mentor Clinical Data Management team members and will direct activities of Arcus Clinical Data Management staff and applicable vendors. The incumbent will contribute to department initiatives and additional non-study projects.
Responsibilities
- Project Manager for DM Tech Team: Understand critical tasks, milestones and initiatives; ensures activities that impact deliverables are met per timelines
- Provide leadership, guidance, training and technology support to the Biometrics department and cross-functional teams as the Clinical Data Systems subject matter expert, ensuring system(s) functionality and performance meet expectations
- Oversee and direct administration of the Arcus Rave URL core configurations, including collaboration with Arcus and Medidata to identify best practices and implement updates
- Develop, review and revise SOPs, guidelines, Work Instructions and templates related to Clinical Data Systems
- Collaborate to develop future strategy for DM Tech Team within Clinical Data Management department
- Strong understanding of maintaining clinical data systems in a validated state in accordance with industry and regulatory validation requirements
- Lead and support DM Tech Team helpdesk and system administration activities; ability to serve as back-up when needed
- Escalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as needed
- Contribute to research and evaluation of new technologies/innovations to improve Clinical Data Management processes
- Support Arcus Global Library and implementation of data standards
- Maintain all Clinical Data Management System internal files, ensuring preparedness for regulatory inspections
- Perform other duties as assigned
Requirements
- Bachelor’s Degree, or commensurate experience, with at least 10 years’ experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center.
- Lead Data Manager experience strongly preferred
- Ability to identify department and operational needs, and drive creation and execution of complex processes and initiatives
- Applied knowledge of ICH, FDA, and GCP regulations and guidelines
- Proven track record of on-time and high-quality Data Management deliverables
- Highly organized, outcome oriented and self-motivated performance
- Ability to adapt to change in a fast-paced work and growth environment
- Experience with EDC systems through full development life cycle. Medidata skills strongly preferred, including Rave iMedidata Cloud User/Site Administration, Rave Lab Administration & Local Lab set-up, Rave Reporter Administration, Rave EDC, Rave Coder & Coding, Rave RTSM, Rave Safety Gateway, and Rave Imaging
- 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 data integrations in EDC from external data sources
- Skill and knowledge in ad hoc data reporting, data review listings, metrics reporting and standards development
- Attention to detail and the ability to work independently within a multi-disciplinary team, as well as with external partners and vendors
- Demonstration of excellent verbal and written communication skills and positive interactions with colleagues
- Successfully communicate CDM technical concepts to other functional groups for broader awareness and understanding, as well as reporting status updates within the Arcus Data Management and Biometrics Department
- Ability to train, mentor, and oversee operational performance of Clinical Data Managers and Clinical Data Systems Specialists within a multi-disciplinary organization, as well as with external partners and vendors
- May manage direct reports
- Ability to effectively manage a variety of data management tasks for multiple clinical studies at different stages of activity
- Oncology experience preferred
- 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 $132,000-182,000 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.
EOE
Arcus 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, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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