Covance

  • Senior Manager, Clinical Data Management

    Job Location(s) UK-Maidenhead | UK-Alnwick | UK-Crawley | UK-Harrogate | UK-Horsham | UK-Leeds | UK-London | UK-Reading | UK-York | NL-Zeist | NL-Amsterdam...
    Job Number
    2018-26571
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

        Senior Manager, Clinical Data Management

    Office Based or Home-Based anywhere in the UK or Netherlands

     

     

    Covance is seeking a Senior Manager with functional leadership to be responsible for delivering data management services to clients and project teams; managing clinical data vendors to achieve the productivity, quality, and timeline requirements of projects; and maintaining optimal department processes and implementing excellent project-specific strategies. 

     

    Additionally, the selected candidate will be responsible for the following:

     

    • Technical data management leadership or oversight on global, large and/or multiple projects with responsibility for the development of project Data Management Plan(s); data management systems set-up; and data accession, data entry and data review specifications and processes; and technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project(s) timelines and budgets.
    • Developing and maintaining a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.
    • Assisting with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs to increase financial margins

     

     

    Education / Qualifications

    Minimum Required:

    • 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, med ical or laboratory technology).
    • Broad knowledge of drug development process.
    • Thorough knowledge of effective clinical data management practices.
    • 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.
    • Thorough knowledge of time and cost estimate development and pricing strategies.
    • Understanding of global clinical development budgets and relationship to productivity targets.

     

    Experience

    Minimum Required:

    • Previous experience of working within clinical data management within a pharma or CRO.
    • Previous technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
    • Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region.
    • 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.
    • In depth knowledge of tracking of staff productivity and quality metrics.
    • Demonstrated skill for mentoring and developing staff on technical and core competencies.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical and biotechnological companies.
    • Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.
    • Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
    • Strong leadership and interpersonal skills.

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