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Translational Operation Manager

Company: AbbVie
Location: Sunnyvale
Posted on: November 11, 2019

Job Description:

General Position Summary/Purpose:The Translational Oncology group at Abbvie uses advanced methods to discover biomarkers and implement Translational Medicine strategies to progress AbbVie's innovative Oncology pipeline. We are currently seeking highly motivated individuals to join our Biomarker Program Management team to support the implementation of Translational Medicine strategies. As a member of project teams, he/she will have the opportunity to work in a highly collaborative environment to support projects across all phases of clinical development. Key Responsibilities Include:

  • Provide hands-on support for operationalizing biomarker research in clinical trials, including sample and data management, and CRO management.
  • Author the Translational sections in key clinical documents including Protocols, Informed Consent Forms, Contracts, and Clinical Study Reports.
  • Use multiple technologies to maintain open and frequent communication with various AbbVie functions such as Site Management & Monitoring and Clinical Operations. Maintain a positive working relationship with internal/external customers. May assist CRA in training sites on sample collection/handling.
  • Manage budget and projections for biomarker section of clinical trials. Review vendor documents such as contracts, Lab Spec review and invoices.
  • Adhere to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs).
  • Level and compensation will be commensurate with experience. Basic Qualifications:
    • Master's Degree in a scientific discipline with 5+ years of related industry and/or academic work experience.
    • Bachelor's Degree in a scientific discipline with 7+ years of related industry and/or academic work experience. Preferred Qualifications:
      • Proficient in the conduct of clinical trials and associated activities and responsibilities, as well as experience interacting with clinical trial teams; strong background in oncology a plus.
      • Previous experience with Clinical Biomarker Operations.
      • Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines.
      • Excellent communication and interpersonal skills, including problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player.
      • Able to work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites/KOL
      • Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
      • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
      • Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus.
      • Understanding of Translational Sciences and Companion Diagnostic development is a plus.
      • Project Management experience a plus. Key Leadership Competencies:
        • Ability to operate independently and learn quickly.

Keywords: AbbVie, Sunnyvale , Translational Operation Manager, Executive , Sunnyvale, California

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