Clinical Data Management Systems Specialist - Lifelancer

Description

The Clinical Data Management Systems Specialist Contractor provides clinical database configuration 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 supporting the Arcus Medidata Rave URL and data management database components of projects, including support modules (e.g., coding, randomization, and trial supply management modules). The incumbent may contribute to department initiatives and additional non-study projects.

Responsibilities

• Primary role will be to serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM and MMI (Imaging)
• Support administration of the Arcus Rave URL core configurations, including collaboration with Arcus and Medidata team to identify best practices and implement updates
• Follow Arcus standard processes and maintain proper documentation in performance of Arcus URL maintenance tasks and implementation of Arcus URL enhancements Follow Arcus specific documentation processes as related to user and site administration activities
• Provides technical support and troubleshooting for site management and user access within RAVE modules
• Escalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as needed
• Support RAVE User Role Configuration and performs updates as needed
• Support Rave Lab Admin configuration as needed Support Arcus Global Library by programming forms, edit checks, and custom functions according to Arcus data collection standards
• 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
• 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
  
  

Requirements

• Bachelors Degree with 2 years’ experience in Clinical Data Management or 4 years’ equivilent 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
• Experience with EDC systems, although Medidata products preferred, through full development life cycle. Medidata areas of interest include Rave EDC, Rave RTSM, Rave Safety Gateway, Rave Imaging, Coder, Lab Management Module and 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 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
• Oncology experience preferred
  
  

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