• Clinical Project Manager

    Job Locations US-IL-Chicago
    ID
    2019-1111
    Category
    Clinical Development
    Type
    Full-Time
  • Overview

    The Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.

    Responsibilities

    • Collaborate with internal and external team members for the planning and execution of Phase I- IV clinical trials.
    • Lead/oversee operational activities to ensure deliverables are prioritized and goals and objectives are met.
    • Assist with development and management of project timelines and budgets
    • Lead the development and oversee the implementation of study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, lab and pharmacy manuals, etc.
    • Assist with identifying clinical investigators and sites.
    • Review clinical study reports and supporting documentation for NDAs or INDs
    • Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs).
    • Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
    • Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
    • Monitor clinical study site activities and visit sites as needed
    • Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO or internal staff.

    Qualifications

    • Minimum BA/BS degree in a science/healthcare field, a nursing degree, or equivalent combined education
    • At least 3 years of Global Clinical Trial Management/Clinical Operations experience required
    • Experience in endocrinology & CNS preferred
    • Must have experience in CRO oversight
    • Detailed knowledge of GCP, ICH Guidelines and current global regulations
    • Competencies: Organizational skills, Project Management, Time Management, Functional Leadership, Teamwork & Collaboration, Independent Judgement, Adaptability, Verbal and Written Communication skills
    • Some domestic and international travel required (up to 35%)
    • Position may require periodic evening and weekend work, as necessary to fulfill obligations

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