Job Properties
  • Job Type
    Full-time Position
  • Category
    Research & Science
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Amsterdam
    • Date Posted
      November 14,2021
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK

    Clinical Research Lead Analyst

    Job Summary

    • Overall management responsibility for pre-market/IDE and post-market clinical studies. Manage clinical strategy and evidence generation plans in close collaboration with R&D, Regulatory Affairs, Market Access, and Medical Affairs personnel. Outline budget requirement and resource allocation for various projects and work closely with Clinical Data Sciences and Clinical Operations for successful execution of study plan. Manage proper collection, analysis, and presentation of clinical data.

    Key Activities & Responsibilities

    • Prepare and develop Evidence generation plans to support legacy products and/or new product development with input from R&D, Marketing, Market Access, Medical Affairs and Regulatory Affairs.
    • Prepare and get buy-in from relevant stakeholders for project budget allocation supporting the strategic clinical studies.
    • Work with Clinical Operations to allocate resources and budgets to achieve successful execution of Stryker Initiated Studies and oversee their progress.
    • Participate in preparation of Clinical Research operating plans and objectives in alignment with company and department strategies.
    • Supervise the implementation of clinical programs and track their progress.
    • Oversee the planning of clinical programs and the development of clinical protocols.
    • Review and approve submissions of protocols and reports to European Notified Bodies, FDA and Institutional Review Boards (IRBs)/Ethics Committees.
    • Interact with Investigators and IRBs on financial and compliance issues.
    • Collaborate with Clinical Data Science Department to establish effective and efficient intra-departmental processes.
    • Collaborate with Clinical Operations Department to establish effective and efficient intra-departmental processes.
    • Oversee the proper collection, analysis and presentation of clinical data.
    • Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases.
    • Oversee development and maintenance of department SOPs.
    • Assure compliance of department activities to EU MDR, FDA regulations, department SOPs, and other regulations.
    • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker’s continuous improvement initiatives.

    Education:

    • Master’s Degree in science or health-related field required; advanced degree in biological sciences, engineering, or related medical/scientific field preferred.

    Qualifications and Work Experience Required:

    • 5+ years experience in conducting pre-market/IDE and/or post-market clinical trials of medical devices.
    • Experience with regulatory submissions, as well as meetings with FDA and/or other regulatory bodies.
    • Experience developing and maintaining department Standard Operational Procedures (SOPs).
    • Applied knowledge of EU MDR, FDA regulations, International Conference Harmonization (ICH), and Good Clinical Practices (GCPs) guidelines.
    • Demonstrated leadership skills.
    • Demonstrated experience working in and fostering a team-based work environment.
    • Applied knowledge of personal computer systems and desktop office application.

    Competencies:

    • Open and confident communication style
    • Strong attention to detail
    • Strong organizational skills, particularly time management and prioritization
    • Open to learn and positive attitude
    • The ability to work as part of a team
    • Strong problem-solving skills

    Reports to

    Sr. Manager, Clinical Research

     
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