1+ months

Principal Scientist Clinical Research

Abbott
Santa Clara, CA 95050

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Provides scientific expertise throughout the development and implementation of clinical evaluations, risk management, and /or clinical studies.

  • Writes/manages clinical evaluation (plans and reports) or clinical trial protocols, protocol amendments, risk master lists, clinical trial registrations and results postings, clinical study project timelines and scientific publications.
  • Interacts with various study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables.
  • Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge to provide  directives to staff as well as study sites as directed by your manager.

    Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

    • Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Conducts team meetings, drafting and sending routine  correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.;
    • Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing  vendor  contracts as requested, and ensuring expenditures are within budgetary guidelines
    • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
    • Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
    • Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
    • Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and  literature, and staying abreast of current clinical practice.
    • Presents scientific data by communicating accurate, succinct summaries of clinical results at industry  gatherings, investigational meetings and regulatory agency meetings.
    • Participates in and supports audits. May actively participate in root cause analysis. May participate in root  cause analysis, preventive or corrective actions, and effectiveness monitoring.
    • Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
    • Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
    • Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team.
    • Provides technical leadership to business units, physicians, and oversees and directs external CROs and medical writers.
    • Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
      • Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Will perform this job in a quality system environment.

        EDUCATION:

        • Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.
        • Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience

          EXPERIENCE

          • Comprehensive knowledge of a technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
          • Is recognized as an expert in work group and across functions.
          • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
          • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
          • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
          • Has broad knowledge of various technical alternatives and their potential impact on the businessDivision: AVD Vascular
            Travel: Yes, 25 % of the Time
            Medical Surveillance: No
            Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2020-02-10 Expires: 2020-04-10

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Principal Scientist Clinical Research

Abbott
Santa Clara, CA 95050

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