Clinical Development Compliance & Training Liaison
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
Application URL: http://www.aplitrak.com/?adid=YXN0YW5pdHMuMTI2MDMuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20