Clinical Development Compliance & Training Liaison



August 7, 2014

Primary Duties:
Reporting to the Clinical Development Compliance & Training Team Lead, and in collaboration with QA& Compliance and functional departmental representatives. the successful candidate will be responsible for Compliance & Training strategic and operational activities for CAPAs, SOPs and Training for their area(s) of focus within Clinical Development.

25% In collaboration with Clinical Development Compliance & Training Team Lead and QA colleagues ensure there is a coordinated, timely and thorough approach to preparation for, and response to, audits and inspections
*  Review audit and inspection findings and identify trends across clinical development areas of focus
*  Ensure the right folks are involved, and participate in, in root cause analysis
*  In collaboration with functional representatives and QA personnel ensure mitigation plans are developed and executed
*  Ensure lessons learned and knowledge sharing occurs to others deemed appropriate
*  Develop tools to enable easy identification of key responsibilities and personnel required to be involved with each audit/inspection type.

25% Oversee and report on compliance with standards, SOPs and processes for the Clinical Development functions assigned on a monthly basis
*  Maintain SOP owners & authors spreadsheet
*  Educate SOP owners & authors on roles and responsibilities
*  Ensure right owners and authors are involved in workgroups to create and/or modify SOPs, guidelines etc.
*  Perform departmental impact assessments relative to procedural documents and update impact assessment report
*  Serve as liaison for functional areas within Clinical Development in OneShire SOP harmonization process
*  Manage SOPs and guidelines for Clinical Development, including ongoing review of existing and development of new where necessary.

30% In collaboration with functional management create develop, implement, maintain and track the role based curricula that will ensure inspection readiness of Clinical Development Colleagues
*  Analyze, design, develop and implement high quality, high value, and cost effective training and communications programs via a variety of media and tools (e.g., on-line, classroom, eLearning, Articulate, Turning Point etc.) in alignment with functional goals and objectives. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining desired results
*  Oversee and report on compliance with GxP required training and ensure appropriate escalation for overdue or out of compliance personnel

10% Manage global Clinical Development training coordination activities
*  Manage Learning Management System administration activities to ensure all clinical development staff (employees/contractors) has appropriate access
*  Executes LMS administration responsibilities on behalf of Clinical Development within the LMS system
*  Define job roles, creates training courses and make assignments for CD courses and mark learner(s) complete
*  Track Clinical Development Compliance & Training metrics and compile reports to be sent out based on agreed upon schedule
*  Manage the CD mailbox and ensure all requests are responded to and/or triaged as per Clinical Development Compliance & Training standards
*  Maintains CD Compliance & Training Moss site
*  Maintain functional websites ensuring up-to-date accurate content based on input from functional leadership, team members, and content owners

10% Participate in Clinical Development initiatives or task forces as appropriate. Support the development, implementation, maintenance and continuous improvement of GCDO Operational Excellence initiatives

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  • Company Shire
  • Contact Name Shire
  • Contact Phone 9999999999
  • Position Location Lexington, Massachusetts
  • Job Reference Code 8517BR
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