• Clinical Document Manager

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(7/1/2019 6:13 PM)
    Job ID
    2019-1245
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Clinical Document Manager will oversee clinical documentation tracking and trial master file activities.  This position is highly visible and interactive with external vendors and cross-functional teams and plays a critical role in eTMF management activities to ensure adherence to established processes and compliance with applicable global regulations.

    Responsibilities

    •Serve as eTMF systems administrator and Subject Matter Expert and interface with eTMF vendor on      system configuration
    •Lead eTMF implementation activities
    •Lead eTMF educational workshops and trainings
    •Develop and maintain trial master file SOPs and work processes including eTMF document workflows    and quality control check criteria
    •Develop and maintain internal data repositories for storage of departmental level information
    •Collaborates with trial execution teams on the proper use of repositories and eTMF systems
    •Ensure clinical trial documentation is consistent with TMF specifications, applicable SOPs, ICH/GCP       guidelines and other regulatory agency requirements
    •Ensures quality checks of TMF content and accuracy of coding are performed
    •Communicates issues to applicable representatives to ensure documents which fail TMF quality   content and/or TMF inspection readiness review are effectively remediated
    •Address TMF questions pertaining document workflows and user questions related to the TMF system
    •Monitor and identify study-specific TMF trends and escalate concerns to trial management lead
    •Ensure the TMF is ‘inspection ready’ throughout the lifecycle of a trial
    •Provide TMF status reports at study team meetings, participates in collaborative efforts and plays an   important cross-functional role in TMF document retrieval and management
    •Maintain up to date knowledge of the TMF Reference Model 3.0, industry best practices and   regulatory considerations as applicable to the job duties
    •Manage TMF Room entry logs, document check in/check out logs, access, and temperature logs
    •Coordinate the long-term storage archival of original documents and maintain document integrity,  per  mandatory retention policies

    Qualifications

    •BS/BA degree or equivalent experience 
    •Minimum 6 years clinical research experience with 4 years relevant document and vendor

      management experience
    •Must be knowledgeable in domestic and global regulatory requirements and guidance’s
    •Extensive TMF experience required, including experience in study start-up, maintenance, close-out,

      and performing quality control and comprehensive completeness reviews
    •Extensive knowledge and application of ALCOAC standard, Good Clinical Practice, Good

      Documentation Practices, and International Council for Harmonization E6(R2) guidelines
    •Subject matter expert level knowledge of clinical study file documents, TMF Reference Model, clinical

      trial activities, and terminology
    •Must have ability to manage and navigate multiple electronic TMF systems and advanced proficiency

      in Word, Excel, PowerPoint and Adobe Acrobat
    •Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with

      shifting priorities
    •Approachable and builds constructive, positive, collaborative relationships with key internal

      stakeholders and external vendors
    •Must be proactive, self-motivated, excel at relationship building, and able to work independently with

      minimal supervision
    •Must have excellent organizational skills, exhibit professionalism, communicate effectively, have a

      can do’ approach, advanced problem-solving skills, and be a team player

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