Manager, Clinical Data Standards
celgene - Basking Ridge, NJ

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BA/BS in a relevant health science or computer science discipline; minimum experience: 5 – 7 years as a clinical programmer/data manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience The primary focus of this position is to act as a Project Standards Manager within the Clinical Data Standards & Integration (CDSI) group, overseeing the activities associated with the consistent implementation of standards for Celgene studies within projects, including studies contracted to Contract Research Organizations (CROs). Responsibilities will include, but are not limited to: 1. Operational Support for Implementation of Celgene Data StandardsDevelop and maintain data standards for one or more projects and for individual studies within the project(s), following Celgene global data standards. Make decisions in conjunction with senior CDSI staff regarding when project data standards can and should deviate from Celgene global data standards.

Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models.Provide input into individual study deliverables with data standards components, including: CRF design, ensuring the same CRF standards (including metadata) are used for all studies in a projectCRF Completion Guidelines to ensure consistency across studies within a project in how and when CRFs are completedProgrammed edit checks to ensure consistency in data meaning across the studies within a projectData transfer specifications to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standardAssist study Data Managers and Clinical Programmers with the validation of SDTM domains, including generation and review of output from software tools such as OpenCDISC. Coordinate feedback from the validation process to vendors who provide the SDTM domainsEnsure availability of resources and development and enforcement of timelines for data transfers required for creation of SDTM domains, and for delivery and validation of SDTM outputsCommunicate and reinforce content and interpretation of SDTM specifications to individual Study Data Managers, Statistical Programmers, Statisticians, and Clinical Programmers, including CRO staff, to ensure consistency in understanding and implementation of standards across a projectAct as the key point of contact for project specific SDTM standards issuesParticipate in Clinical Team and Study Team meetings as needed, specifically in a supportive capacity 2. Standards Support for SubmissionsDevelop overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used.Determine which studies in a submission require coding upgrades for the purposes of data integrationWork with the Submission Team to prepare pre-NDA correspondence on submission datasetsProvide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirementsDevelop plan and assure resources are available for timely provision of SDTM-related submission deliverables (e.g., SDTM annotated CRF, define.pdf and/or define.xml file, XPT files)Represent the CDSI group on project Submission Team(s) 3. Other Key ActivitiesAuthor, review, and approve SOPs and Working Practices applicable to the Clinical Data Standards & Integration (CDSI) group or the Clinical Data Operations, Systems, and Standards (CDOSS) departmentAssist in developing job descriptions for department and managing more junior personnel, as requiredConduct special projects as assigned Share best practices Skills/Knowledge RequiredBA/BS in a relevant health science or computer science discipline; minimum experience: 5 – 7 years as a clinical programmer/data manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience.

Medical or mathematics/computer science background a plus.Strong working knowledge of the Study Data Tabulation Model and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.Strong project management and negotiation skillsComputer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus.Experience in CRF design, query resolution, and data validationGood communication skills; ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmersSubmission experience - 2 years ago - save job
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.