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Senior Manager Clinical Operations

Company: Spectrum Pharmaceuticals Inc.
Location: Irvine
Posted on: July 14, 2019

Job Description:

Summary: Designs, implements and monitors clinical studies of compounds designated for clinical development. Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials.

Responsibilities:


  • Interacts with data management personnel to plan data entry and analysis; recruits/screens/selects competent investigators; organizes investigators' meetings; assures that Good Clinical Practices (GCPs) are followed;

  • Assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion or termination of studies (in cooperation with statistical staff).

  • Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetics and pre-clinical studies.

  • Prepares clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.

  • Plans clinical programs and develops a timetable, budget and resource analysis for clinical programs and personnel administration.

  • Establishes and maintains relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities.

  • Prepares manuscripts for technical journals and makes presentations at scientific meetings

    Skills, Education and Experience:


    • Require a MD/PhD in a relevant scientific discipline



      • A minimum of 5-8 years' experience in clinical research.-

        Availability:


        • Must be available to work in the evenings and weekends, as required.


          Position Location and/or Territory and Travel


          • Position is located in Irvine, CA.

          • Position will require up to_60_% travel (or) occasional local travel


            Required Skills

            Required Experience

            Job Location

            Irvine,

Keywords: Spectrum Pharmaceuticals Inc., Irvine , Senior Manager Clinical Operations, Executive , Irvine, California

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