Clinical Data Management Systems Specialist Contractor (RAVE Admin) (Office OR R

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.ResponsibilitiesPrimary 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 updatesFollow Arcus standard processes and maintain proper documentation in performance of Arcus URL maintenance tasks and implementation of Arcus URL enhancementsProvides technical support and troubleshooting for site management and user access within RAVE modulesEscalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as neededSupport RAVE User Role Configuration and performs updates as neededSupport Rave Lab Admin configuration as neededSupport Arcus Global Library by programming forms, edit checks, and custom functions according to Arcus data collection standardsAttend 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 activitiesAttend trainings as applicable to assist in performance of activities related to job functionsParticipate in departmental development initiatives (i.e., SOPs, Work Instructions, Guidelines, and templates)Maintain all data management internal files, ensuring preparedness for regulatory inspectionsPerform other duties as assignedRequirementsBachelor's Degree with 2 years’ experience in Clinical Data Management or 4 years’ equivalent experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic CenterPractical knowledge of ICH, FDA, and GCP regulations and guidelinesProven track record of on-time and high-quality Data Management deliverablesHighly organized, outcome oriented and self-motivated performanceAbility to adapt to change in a fast-paced work and growth environmentExperience 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 desirableGeneral knowledge of industry standards and best practices such as CDISC/CDASHKnowledge of and experience with MedDRA and WHO Drug data dictionariesFamiliarity with data integrations in EDC from external data sourcesSkill and knowledge in ad hoc data reporting, data review listings and metrics reportingAttention to detail and the ability to work independently within a multi-disciplinary team, as well as with external partners and vendorsDemonstration of excellent verbal and written communication skills and positive interactions with colleaguesSuccessfully 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 DepartmentAbility to train, mentor, and oversee other CDMs within a multi-disciplinary team, as well as with external partners and vendorsOncology experience preferred

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