Covance

  • Clin Data Mgr I

    Job Location(s) UK-Maidenhead | DE-Berlin | IT-Milan | PT-Lisbon | ES-Madrid
    Job Number
    2018-23789
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    Covance is seeking a Clinical Data Manager to work within their Late Phase Data Management Department. You will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.

     

    This role is permanent full time, office or homebased in the UK, Germany, Italy, Spain or Portugal.

     

    Responsibilities/Duties:

     

    • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
    • Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
    • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
    • Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
    • Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
    • Review data acquisition conventions and data review guidelinesIdiagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion monitoring conventions.
    • Coordinate the development and testing of data management systems editIdata validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
    • Interact and collaborate with other project and speciality team members (clinical, programming, statistics, CDM technical support, drug safety, ) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
    • Advanced planning and risk management for projects(issue escalation, resource  management).
    • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
    • Assist with goal creation and performance review assessment for data review project staff.
    • Maintain technical data management competencies via participation in internal and external training seminars.
    • Ensure project staffs are trained and adhere to project-specific, global, standardized data management processes.
    • Identify areas for process and efficiency improvement and implement solutions on assigned projects.
    • Support achievement of project revenue and operating margin for data management activities to agreed targets.
    • Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
    • Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Review literature and research technologies/procedures for improving global data management practices.
    • Perform other duties as assigned by management.

    Education / Qualifications

     

    • University/college degree (life science, pharmacy or related  subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
    • Additional relevant work experience will be considered in lieu of formal qualifications.
    • Broad knowledge of drug development process.
    • Understanding of global clinical development budgets and relationship to productivity targets.
    • Knowledge of effective clinical data management practices.
    • Knowledge of time and cost estimate development and pricing strategies.
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

    Experience

     

    • Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
    • Demonstrated skill for technical management of staff exceeding 5 employees.
    • Financial management of gross revenues in excess of $250K per year.
    • Excellent oral and written communication and presentation skills.
    • In  depth   knowledge  of  clinical  trial   process  and   data  management,  clinical  operations, biometrics, quality management, and systems applications to support operations.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.

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