• Clinical Project Manager

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1083
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Clinical Project Manager is responsible for managing clinical trials from initiation to completion through leading the development of study protocols, case report forms and clinical reports, as well as overseeing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. This individual will support clinical trials as required with developing and updating clinical trial documents including protocol, investigators brochure, and informed consent documents. Additional responsibilities may include working with and documenting activities of the Data and Safety Monitoring Committee (DSMC) as needed.

    Responsibilities

    • Responsible for the design and implementation of pre-market and post-market clinical trials
    • Develop and manage the project plan including a budget and timeline
    • Facilitate the development of study protocols by coordinating input from various sources including literature, experts, and internal team members
    • Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories
    • Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process and study objective
    • Ensure monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective
    • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
    • Manage the clinical study report as well as the clinical portion of regulatory submissions
    • Prepare scientific abstracts and manuscripts
    • Perform other clinical duties when requested
    • Position supervises Clinical Research Associates and Clinical Trial Associates



    Qualifications

    • Bachelor’s degree in health profession, science and/or engineering field
    • A minimum of six years of clinical operations experience in the pharmaceutical or medical device industry
    • Previous experience leading a clinical study strongly preferred
    • Excellent written and oral communication skills
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Excellent organizational skills and attention to detail
    • Ability to manage projects and resources
    • Some travel would be required for site selection and training, monitoring responsibilities and educational seminars
    • Ability to multi-task and work effectively in a team or independently with a focus on meeting deadlines
    • Ability to travel approximately 35% depending on study status
    • Ophthalmology experience preferred, but not required

     

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