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Inspection Readiness TMF Manager

In New Jersey / United States

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Inspection Readiness TMF Manager   

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JOB TITLE:

Inspection Readiness TMF Manager

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Somerset New Jersey / United States

JOB DESCRIPTION:

The Inspection Readiness TMF Manager is a key member of the TMF inspection readiness team. This individual has a keen knowledge of GCP and the impact of GCP issues on potential inspection risks. The Inspection Readiness TMF Manager reviews the TMF with a focus on identifying inspection risks.

Job Responsibilities

  • Perform the TMF Inspection Readiness (IR) Review of the TMF for assigned studies
  • Conduct activities to support start of IR TMF review activities including review of the IR Plan, key study plans, and the protocol
  • Provide IR team training related to the protocol and study plans
  • Perform IR TMF review as per client requirements and IR Plan focusing on identifying GCP risks
  • Assign completeness review tasks to TMF Specialist and perform oversight of these reviews
  • Manage document queries to ensure that they accurately reflect TMF gaps and inspection risks
  • Resolve queries to ensure that the TMF is inspection ready
  • Identify GCP issues and communicate to sponsor through queries and summaries
  • Prepare summary of site review for client to assist in site preparation activities
  • Escalate critical GCP issues to Lead
  • Provide oversight to review and follow-up of Query Log
  • Review and follow up with appropriate party on open queries and ensure adequate resolution
  • Work with the Lead and study team to address trends in issues to mitigate risk
  • Partner with assigned TMF Manager to ensure that scope of review is adequately resourced and ensure there are no overlaps in review activities
  • Support clients during inspection activities as needed
  • Perform TMF management activities as required by project resourcing
  • Oversee the development of the study specific TMF Map
  • Monitor metrics to assess the completeness and quality of the TMF
  • Work with external partners and study team to address gaps, issues, and mitigate risks
  • Conduct Investigator Site Health Authority inspection preparation visits
  • Identify tools from the study to support the site preparation
  • Review the Investigator Site File to identify gaps or potential inspection issues
  • Review select source documents to identify potential inspection issues
  • Assist the site in remediating and gaps
  • Conduct practice interviews with site staff to ensure their preparation for the potential inspection
  • Provide coaching to site staff based on their responses during the interviews
  • Support the investigator site during actual health authority inspections
  • Provide updates to sponsor during actual health authority inspections
  • Provide support, direction and coaching to employees in the areas of GCP compliance
  • Participate in the development of tools and methods for IR activities
  • Provide leadership within the inspection readiness team
  • Qualifications and Education Requirements

  • Extensive knowledge of global regulatory requirement and inspection activities
  • Minimum of 5 years working in a GCP environment
  • Experience preparing for/participating in health authority inspections
  • Knowledge of drug development process
  • Preferred Skills

    • Experience working with a variety of TMF systems and ability to learn new technologies with ease
    • Strong computer skills including Outlook, MSWord and MS Excel
    • Good communication skills
    • Excellent problem-solving skills through critical thinking
    • Excellent attention to detail
    • Excellent organizational, time management, and multi-tasking skills

    Position Details

    POSTED:

    Jul 05, 2021

    EMPLOYMENT:

    INDUSTRY:

    SNAPRECRUIT ID:

    S16204867773957326

    LOCATION:

    New Jersey / United States

    CITY:

    Somerset

    Job Origin:

    CEIPAL_ORGANIC_FEED

    A job sourcing event
    In Dallas Fort Worth
    Aug 19, 2017 9am-6pm
    All job seekers welcome!

    Inspection Readiness TMF Manager    Apply

    Click on the below icons to share this job to Linkedin, Twitter!

    The Inspection Readiness TMF Manager is a key member of the TMF inspection readiness team. This individual has a keen knowledge of GCP and the impact of GCP issues on potential inspection risks. The Inspection Readiness TMF Manager reviews the TMF with a focus on identifying inspection risks.

    Job Responsibilities

  • Perform the TMF Inspection Readiness (IR) Review of the TMF for assigned studies
  • Conduct activities to support start of IR TMF review activities including review of the IR Plan, key study plans, and the protocol
  • Provide IR team training related to the protocol and study plans
  • Perform IR TMF review as per client requirements and IR Plan focusing on identifying GCP risks
  • Assign completeness review tasks to TMF Specialist and perform oversight of these reviews
  • Manage document queries to ensure that they accurately reflect TMF gaps and inspection risks
  • Resolve queries to ensure that the TMF is inspection ready
  • Identify GCP issues and communicate to sponsor through queries and summaries
  • Prepare summary of site review for client to assist in site preparation activities
  • Escalate critical GCP issues to Lead
  • Provide oversight to review and follow-up of Query Log
  • Review and follow up with appropriate party on open queries and ensure adequate resolution
  • Work with the Lead and study team to address trends in issues to mitigate risk
  • Partner with assigned TMF Manager to ensure that scope of review is adequately resourced and ensure there are no overlaps in review activities
  • Support clients during inspection activities as needed
  • Perform TMF management activities as required by project resourcing
  • Oversee the development of the study specific TMF Map
  • Monitor metrics to assess the completeness and quality of the TMF
  • Work with external partners and study team to address gaps, issues, and mitigate risks
  • Conduct Investigator Site Health Authority inspection preparation visits
  • Identify tools from the study to support the site preparation
  • Review the Investigator Site File to identify gaps or potential inspection issues
  • Review select source documents to identify potential inspection issues
  • Assist the site in remediating and gaps
  • Conduct practice interviews with site staff to ensure their preparation for the potential inspection
  • Provide coaching to site staff based on their responses during the interviews
  • Support the investigator site during actual health authority inspections
  • Provide updates to sponsor during actual health authority inspections
  • Provide support, direction and coaching to employees in the areas of GCP compliance
  • Participate in the development of tools and methods for IR activities
  • Provide leadership within the inspection readiness team
  • Qualifications and Education Requirements

  • Extensive knowledge of global regulatory requirement and inspection activities
  • Minimum of 5 years working in a GCP environment
  • Experience preparing for/participating in health authority inspections
  • Knowledge of drug development process
  • Preferred Skills

    • Experience working with a variety of TMF systems and ability to learn new technologies with ease
    • Strong computer skills including Outlook, MSWord and MS Excel
    • Good communication skills
    • Excellent problem-solving skills through critical thinking
    • Excellent attention to detail
    • Excellent organizational, time management, and multi-tasking skills


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