Senior Clinical Data Management Systems Specialist (RAVE) (Office OR Remote)

Description

The Senior Clinical Data Systems Specialist provides Data Management Tech Team expertise and support 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 database build activities. This position may train Clinical Data Management team members and may support activities of Arcus Clinical Data Management staff, CRO and Database Vendors. The incumbent may contribute to department initiatives.

Responsibilities

• Manage administration of the Arcus Rave URL activities: Lab Administration, Report Administration, eLearning, User Roles and Core Configuration.
• Provide technical support for Rave study development, Rave URL modules, and site management/user access within Medidata Client Division
• May lead development of study database development, including but not limited to, programming of clinical database according to CRF Specifications and programming of edit checks (edit checks, derivations, and custom functions) according to Edit Check Specifications.
• Support Arcus Global Library by programming forms, edit checks (edit checks, derivations, and custom functions) according to Arcus data collection standards
• May support Clinical Data and SAS Programming activities
• May serve as system administrator to grant user and site access using Medidata Cloud Administration for Rave (EDC and Modules), Coder, RTSM and MMI (Imaging)
• Follow Arcus standard processes and maintain proper documentation in performance of Medidata product administration and development activities within the Arcus Medidata Client Division and Rave URL
• Maintain all data management internal files, ensuring preparedness for regulatory inspections
• Escalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as needed
• Attend meetings with Arcus and Medidata teams to discuss agenda items related to maintenance of Arcus Rave URL related activities
• Represent DM Tech Team on cross-functional teams, providing accurate Arcus Rave URL and study database status updates, timelines, and proactive communication of data management deliverables and potential risks and mitigations
• Attend trainings as applicable to assist in performance of activities related to job functions
• May participate in departmental development initiatives (i.e., SOPs, Work Instructions, Templates, Work Aids, etc.)
• Performs other duties as assigned

Requirements

• Bachelor's Degree with 3 years’ experience in Clinical Data Management or 5 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 3+ years performing Medidata study builds strongly preferred
• Desired Administration knowledge of following Medidata areas of interest including Cloud Administration, Rave (EDC and Modules), RTSM, Rave Safety Gateway, MMI (Imaging), Coder, and overall URL management
• Medidata Custom Function programming experience preferred
• General knowledge of industry standards and best practices such as CDISC/CDASH/SDTM
• 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 Clinical Data Management 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 and mentor more junior level Clinical Data Systems Specialists
• Ability to train and mentor within a multi-disciplinary team, as well as with external partners and vendors
• Oncology experience preferred
• Minimal to no travel required

Physical Requirements: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.