Job Information
Immunocore LLC Clinical Compliance/Inspection Readiness, Manager - Clinical Operations in Conshohocken, Pennsylvania
Vacancy Name
Clinical Compliance/Inspection Readiness, Manager - Clinical Operations
Vacancy No
VN514
Employment Type
Full Time
Location of role
Conshohocken, PA or Gaithersburg, MD
Department
Clinical Operations
Key Responsibilities
The Clinical Compliance/Inspection Readiness, Manager is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues. This onsite position can be located at either our Gaithersburg, MD or Conshohocken, PA sites.
KEY RESPONSIBILITIES
Lead the development and delivery of GCP and Inspection Readiness training for the Clinical o organization
Lead the development and implementation of processes and tools to support teams and functions in being inspection ready
Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring
Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding
Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities
Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
Generate, analyze and communicate inspection readiness metrics
Drive continuous improvement into inspection readiness and inspection conduct support
Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards
Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization
Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)
Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance
Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (
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