Manager, Clinical Data Systems (Office OR Remote)

DescriptionThe Manager, Clinical Data Systems provides oversight and guidance of clinical database development, core configuration of database URL, and site and user access management expertise to project teams. 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 managing all aspects of the Arcus Medidata Rave URL and data management database components of projects, including support modules (e.g., coding, randomization, and trial supply management modules). This position may participate in database development, including assisting with user acceptance testing. This position may mentor Clinical Data Management team members and may direct activities of Arcus Clinical Data Management staff, CRO and Database Vendors. The incumbent may contribute to department initiatives and additional non-study projects.ResponsibilitiesManage administration of the Arcus Rave URL core configurations, including collaboration with Arcus and Medidata team to identify best practices and implement updates.Serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM and MMI (Imaging).Provide oversight, guidance, and design of study build activities on Arcus Rave URL.Support Arcus Global Library by programming forms, edit checks, and custom functions according to Arcus data collection standards.Provide technical support and troubleshooting for Rave study development as well as site management and user access within supported RAVE modules.Escalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as needed.Manage Arcus Medidata Specification documents (Coder, Lab Administration, Core Configuration, etc.) and perform updates as needed.Follow Arcus standard processes and maintain proper documentation in performance of all Arcus URL activities.Attend meetings with Arcus team and external vendors to discuss routine and non-routine agenda items related to maintenance of Arcus URL, core configuration, and related activities.Attend trainings as applicable to assist in performance of activities related to job functions.Represent data management on cross-functional teams, providing accurate Arcus URL and study database status updates, timelines, and proactive communication of data management deliverables and potential risks and mitigations.Participate in departmental development initiatives (i.e., SOPs, Work Instructions, Guidelines, and templates).Maintain all data management internal files, ensuring preparedness for regulatory inspections.Perform other duties as assigned.RequirementsBachelor's Degree with 5 years’ experience in Clinical Data Management or 6-8 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.Highly organized, outcome oriented and self-motivated performance.Ability to adapt to change in a fast-paced work and growth environment.Certified Medidata Study Builder or 5+ years performing Medidata study builds strongly preferred.Desired Administration knowledge of following Medidata areas of interest including Rave EDC, Rave RTSM, Rave Safety Gateway, Rave Imaging, Coder, Cloud Administration and overall URL management.Medidata Custom Function programming experience preferred.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 data integrations in EDC from external data sources.Skill and knowledge in ad hoc data reporting, data review listings and metrics reporting.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 other CDMs within a multi-disciplinary team, 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 $143,000- $163,000 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 identity, 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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