• Director, Clinical Operations

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(8/6/2019 4:51 PM)
    Job ID
    2019-1248
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Director, Clinical Operations is responsible for day to day oversight of the teams executing clinical studies.  This position works closely with function leads (i.e. clinical monitoring, clinical document management, clinical project management, data management, and biostatistics) to ensure studies are inspection ready throughout their lifecycles.  May serve as function lead when needed.

    Responsibilities

    • Contributes to integrated development plans
    • Selects operational model to be applied to a given study
    • Implements the vendor performance management and broad operational metrics monitoring program
    • Participates in the maintenance of the Clinical Quality Management System
    • Conducts regular assessments of cross-functional team resources and external service providers as appropriate
    • Oversees day-to-day execution activities and implements any training needed to ensure activities are conducted in compliance with company SOPs, expectations and pertinent regulations
    • Coaches function managers/leads on the use of clinical project management methodology to develop and effectively manage timelines, budgets and resources
    • Conducts inspection readiness checks and ensures identified issues are resolved
    • Compiles performance updates for functional area leadership and may present updates to management team

    Qualifications

    • Bachelor’s degree or higher in health profession, science and/or engineering field
    • A minimum of 14 years’ experience in the pharmaceutical industry, including 12 years of relevant clinical research experience, 6 years supervisory experience, and 2 years in a leadership role
    • Excellent written and oral communication skills
    • Strong project management skills and analytical skills
    • Strong working knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
    • Excellent organizational skills, integrity, and attention to detail
    • Ability to think proactively, strategically and creatively
    • Strong interpersonal skills with ability to work in a team environment as well as independently
    • Ability to assimilate new information rapidly, multi-task, and work across multiple projects
    • Computer literacy, proficiency in MS Office, MS Project, etc.
    • Ability to travel approximately 35-40%

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