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Inspection Readiness TMF Manager
Location: US-NJ-Somerset
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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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