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Configuration & QC Manager
at ICON plc
Job Reference #: 060131
Categories: Management - Mid-Level (Manager, Director)
Configuration & QC Manager
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• Work closely with PM Management in reviewing incoming study Configuration and QC Requests and prioritize according to timelines and client requirements.
• Assign studies to the Configuration & QC Team according to priority requests determined in conjunction with PM Management.
• Organize workflow and processes within the team and implement process improvements with CS Leadership.
• Organize and implement training schedule for new Configuration & QC staff. Mentor and coach staff, so as to develop their on the job skills, encourage continuous learning and maximize growth potential
• Review and update SOPs, process flows and all training materials, with a view to quality improvements across all processes and workflows.
• Work closely with the PM team in interpreting the CLW specs and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification
• Provide PM with configuration support by entering selected elements of the study's specifications into ICL systems (e.g. PACS, LIMS, and ICOLIMS).
• Create supporting documents for sites that facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, study-specific Lab Manuals, and collection guides. • Support PM in the creation of all configuration-related forms, such as Value Calculation Forms and the LIS Forms.
• Assist PM in preparing pdf documents for links to ICOLIMS and Read Only drive posting.
• When updates or additions are required for collection, packaging, shipping instructions or contact information to a study-specific Lab Manual or Requisitions, work with CS Leadership to determine whether or not those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.
• Perform new study configuration quality checks on all databases, internal forms and supporting documents to ensure high quality output and adherence to the CLW specs.
• Perform level-appropriate quality checks on database and document updates for all amendments performed by PM.
• Verify and post documents for Read Only access once finalized, checking for adherence to version history and version control procedures.
• Provide technical support and guidance to PM for all study configuration tasks
• Review process flows and work with leadership toward quality improvements as appropriate