Clin Data Mgr I - Medical Device

Job Overview:Leads aspects of data management including, but not limited to:Designing CRF’s, CRF completion guidelines, database user requirements, technical requirements;Creating data management plans;Performing ongoing data review, medical coding, e.g., of adverse events, medical history; or concomitant medications;Coordinating and facilitating User Acceptance Testing (UAT);Reviewing protocol and clinical study reports for data management content;Creating and maintaining tools for efficient management of the project;Creating or reviewing all other data management-related study documents and validation efforts;Overseeing data validation efforts, including plan and report generation, staff training, validation oversight and corrections.Managing study records related to Data Management responsibilities for the Trial Master File.Develops, validates and maintains databases in accordance with customer and regulatory requirementsRecommends solutions to internal project teams and Covance Medical Device and Diagnostic Solutions’ clients as necessary.Interprets and implements 21 CFR, Part 11 requirements.Participates in establishing and maintaining Clinical Trial Management (CTMS) and/or electronic regulatory binder features and functionality and new module features and functionality (e.g., safety, adjudication, device accountability, monitoring) standardization.Develops and maintains project timelines and budgets and reports any issues to project manager.Analyzes and reports all study issues to supervisor, project manager, and/or sponsor, as appropriate.Works with Biostatisticians and clinical project managers to define reports, edit checks, new database features, etc.Interacts with Biostatisticians and clinical project managers to further Covance Medical Device and Diagnostic Solutions’ use of database features and modules.Serves as database user expert.Ensures compliance with Covance and applicable sponsor SOPs.Assists in the creation and management of internal training, data standardization and/or SOPs.Participates in client meetings, as necessary.Attends applicable internal and external training programs each year.Contributes to Business Development activities, as required, which may include, but not be limited to:Actively marketing Covance Medical Device and Diagnostics data management services to current and potential clients;assisting in marketing efforts of Covance Medical Device and Diagnostics services and database solutions to current and potential clients;assisting in the preparation of client proposals and work orders, and attending bid defense meetings.May perform dual roles as Project Manager, as necessary.Other duties as assigned. Education/Qualifications:Science, IS, health-related, or technical Bachelor’s degree.Excellent communication and interpersonal skills.Strong organizational skills.Detail-oriented.Ability to travel up to 20% time preferred.Experience with clinical systems, including data management, EDC, and Clinical Trial Management Systems (CTMS) experience is required.Database development and/or validation experience is required.Highly proficient with MS Office. Solid understanding of software capabilities and business applications.Ability to independently handle multiple tasks and prioritize with minimalUnderstands the importance of building and maintaining client relationships and providing excellence in service delivery. Experience:Minimum of five years of data management and/or clinical experience      preferred with at least three specifically in data management.

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