[Next-Generation Sequencing Book]
  • [Photo] Jessica Cartmel • December 23, 2008

    BACKGROUND

    Shape Your Future And Ours. Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world.

    RESPONSIBILITIES

    Manager, Global Clinical Research Quality. Supports on a daily basis, Schering-Plough’s Global Clinical Research (GCR) to facilitate clinical trial operational compliance and process excellence. Core activities include (but are not limited to):
    • Provide process guidance to GCR colleagues within Headquarters functions to facilitate clinical trial quality assurance and compliance with GCP and clinical and operational standards. The areas to be covered include: Global Clinical Data Management, Statistics, Global Scientific Programming, Medical Communications and Clinical Documentation, and Clinical Trial Safety.
    • Provide Subject Matter Expert support on cross-functional teams developing Quality Management Systems, standards, SOPs and related training material in relation to clinical trial processes.
    • Develop global quality assurance verification plans for clinical research activities and ensure execution by regions.
    • Support the SP Global Inspection Organization (GIO) and clinical audit teams to facilitate overall readiness and responsiveness of GCR for internal and external audits and inspections.
    • Develop metrics for clinical research activities such as Data Management, Statistics, Global Scientific Programming, Medical Communications and Clinical Documentation and Clinical Trial Safety and perform trend analysis.

    REQUIREMENTS

    Bachelor's Degree in an appropriate science (e.g., Biology, Nursing, Medical Technology, Pharmacy) and 5 years experience in clinical research (including Clinical Data Management or Clinical Programming) or Bachelors Degree in an appropriate science and 2 years clinical research quality assurance/quality control experience/compliance related area.
    • Experienced in GCP, preferably within Clinical Data Management, Statitics or Clinical Programming.
    • Solid understanding of FDA and/or EU-CTD regulations (depending on location) and ICH GCP guidelines; including an understanding of system validation and CFR 21 Part 11.
    • Proven ability to synthesize various regulations governing the conduct of clinical research and apply relevant information to support the development of standards, SOPs and related training material
    • Familiar with quality control procedures within clinical setting, including clinical system development
    • English language proficiency required.
    • Excellent verbal and written skills; able to interact with peers, subordinates and superiors in a positive and influential manner
    • Strong orientation to problem solving. Ability to work within a team to develop solutions highly desirable
    • Must be detail oriented with an ability to work independently as well as within a large matrix organization
    • Must be effective at managing multiple demands and competing priorities in a fast-paced and dynamic company
    • Have the ability to travel locally and internationally if required (approx 10-20%)

    HOW TO APPLY

    Please copy and paste the following link into your browser address bar:
    http://appclix.postmasterlx.com/track.html?pid=402881bd1e48ea6f011e4bb24b22078a&source=minejob

    ARTICLE: Req. Number: 23499BR

    DEADLINE: 01/18/2009

    Schering-Plough is an equal opportunity employer. M/F/D/V

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