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Labcorp Senior Clinical Data Manager - Medical Device & Diagnostics in Helana, Montana

Job Overview:

Labcorp Drug Development is seeking candidates for a Senior Clinical Data Manager within the Medical Device & Diagnostics team. The Senior Clinical Data Manager can be remotely located anywhere within the United States or Canada.

  • 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 requirements

  • Recommends solutions to internal project teams and Labcorp Drug Development by Labcorp clientele 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 Labcorp Drug Development's use of database features and modules.

  • Serves as database user expert.

  • Ensures compliance with Labcorp Drug Development 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 Labcorp Drug Development data management services to current and potential clients;

  • Assisting in marketing efforts of Labcorp Drug Development 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 (Information Systems), health-related, or technical Bachelor’s degree.

  • Excellent communication and interpersonal skills.

  • Strong organizational skills.

  • Detail-oriented.

  • Understands the importance of building and maintaining client relationships and providing excellence in service delivery.

  • Highly proficient with MS Office. Solid understanding of software capabilities and business applications.

  • Ability to independently handle multiple tasks and prioritize with minimal oversight.

Experience:

  • Minimum of five years of data management and/or clinical experience preferred with at least three specifically in data management.

  • Experience with clinical systems, including data management, EDC, and Clinical Trial Management Systems (CTMS) experience is required.

  • EDC experience with MedNet, IBM Clinical, or Medidata Rave are preferred.

  • Medical Device and/or diagnostics experience is preferred.

  • Database development and/or validation experience is required.

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