Dana G. Baird
Charlottesville,USA
Summary
A highly motivated, detail oriented and quality driven manager of Process Improvement, Project Delivery, Learning Development and Document Management with over 27 years experience in the clinical research industry. An experienced people leader of diverse, global teams with a focus on the creation of an inclusive work environment and employee growth and development.
Overview
28
28
years of professional experience
Work History
Senior Manager, Quality & Compliance
ICON Clinical Research
Charlottesville, USA
06.2023 - Current
- Lead a global document control team, responsible for the curation of all documentation in ICON’s electronic document management system, providing strategic guidance that promotes compliance with regulatory requirements and good documentation practices
- Provide solution-oriented direction to lead successful process improvement to business problems and projects
- Provide process improvement methodologies and coach internal customers on successful sustainable process improvement
- Responsible for Audit/Inspection Findings and CAPA Management for Global Document Control
- Act as advisor to Leadership and customers on quality management principles and applications
- Prepare and present at Sponsor Audits and Inspections (FDA, EMA, MHRA and other authorities) to ensure foundational understanding of document control processes and compliance with all applicable regulatory requirements
- Present at Senior Leadership Meetings to promote compliance with EDMS and best practices
- Collaborate with the Business System Owner and System Administrators to identify and support with the implementation of system updates and improvements to the EDMS
- Hiring, Onboarding and mentoring new team members and supporting the recruitment of other roles within the department
- Responsible for the evaluation of all EDMS document creations and the modification and retirement of existing processes to ensure compliance with internal process, regulatory and business requirements
- Partner with Learning Management System Owners to collaborate on training process and requirements
Principal Process Analyst
ICON Clinical Research
Charlottesville, USA
04.2017 - Current
- Company Overview: formerly PRA Health Sciences
- Performed analysis of process documentation and training materials in collaboration with process owners, business unit leaders, department management and Quality Assurance
- Prepared and edited business support documentation (SOPs, flowcharts, learning assessments, Work Instructions, training/communication materials, etc.)
- Acted as liaison between the Quality Management System and the internal customer, providing consultation on good process design and standards for controlling documentation, and ensuring that other ongoing initiatives, with similar constraints/dependencies are considered; small and large teams, globally
- Supported the on-going maintenance and health of the Quality Management System
- Managed project assignments to required timelines and quality standards
- Supported the Quality Management System and Learning Management System best practices and alignment
- Interviewed, onboarded and mentored new hires
- Participated in Sponsor audits and inspections
- Member of Executive Leadership Corporate Compliance Committee providing oversight of development and maintenance of processes/policies while collaborating with Learning Management System to include training aspects
- Formerly PRA Health Sciences
Manager, Quality & Compliance
ICON Clinical Research
Charlottesville, USA
04.2017 - 06.2023
- Company Overview: formerly PRA Health Sciences
- Led global document management team to support ICON’s electronic document management system, providing strategic guidance that promotes compliance with regulatory requirements and good documentation practices while also supporting the system configuration and continual compliance with quarterly vendor releases
- Led complex GCP audits, including regulatory inspections by the FDA, EMA, MHRA and other authorities
- Design, development, implementation and maintenance of new electronic document management system including the migration of legacy EDMS documentation into the new system
- Led two document control teams (legacy companies) and two electronic document management systems post company acquisition (ICON of PRA Health Sciences)
- Acted as advisor to management and customers of both legacy companies on document control/ quality management best practices and applications
- Hiring, Onboarding and mentoring new team hires
- Formerly PRA Health Sciences
Process Analyst 3
ICON Clinical Research
Charlottesville, USA
10.2009 - 04.2017
- Company Overview: formerly PRA Health Sciences
- Formerly PRA Health Sciences
Process Analyst 2
ICON Clinical Research
Charlottesville, USA
07.2007 - 10.2009
- Company Overview: formerly PRA Health Sciences
- Formerly PRA Health Sciences
Process Analyst
ICON Clinical Research
Charlottesville, USA
08.2005 - 07.2007
- Company Overview: formerly PRA Health Sciences
- Formerly PRA Health Sciences
Technical Writer 2
ICON Clinical Research
Charlottesville, USA
05.2004 - 08.2005
- Company Overview: formerly PRA Health Sciences
- Research new/existing products and specifications to provide technical guidance to documentation
- Create and deliver strategic communication/presentations to business partners and executive leadership
- Serve as subject matter expert on technical documentation; develops documentation standards
- Mentor junior level technical writers
- Develop process documentation, including support for mapping and training
- Led work sessions with subject matter experts, small and large, globally and locally
- Knowledge of good documentation practices and applicable regulatory requirements
- Formerly PRA Health Sciences
Global Standard Operating Procedure (SOP) Administrator
ICON Clinical Research
Charlottesville, USA
07.1997 - 05.2004
- Company Overview: formerly PRA Health Sciences
- Perform Quality Management System and Learning Management System Audits
- Design, develop, deploy, train and maintained a global standard operating procedure program across multiple Legacy ICON (PRA Health Sciences) locations
- Design, development and implement/present during Sponsor Audits and Inspections
- Travel to all Legacy ICON (PRA Health Sciences) locations to educate employees on the good documentation practices, the Quality Management System and the use of standard operating procedures/policies
- Formerly PRA Health Sciences
Education
Undergraduate, Bachelors - English
University of Virginia
Charlottesville, VA, USA05.1994
Undergraduate, Associates -
Piedmont Virginia Community College
Charlottesville, VA, USA06.1991
Skills
- Quality Docs Electronic Document Management System
- MetricStream Document Management System
- DataBasics
- WorkDay
- TrackWise Digital
- Cornerstone on Demand Learning Management System
- MS Office Applications (Word, Excel, Visio, PowerPoint, OneDrive, OneNote, Outlook, SharePoint, TEAMS)
- Organizational development
- Cross-functional team coordination
- Data-driven decision making
- Cross-functional team leadership
- Influencing and negotiating
- Innovation management
- Data analytics
- Troubleshooting and problem resolution
- Organizational improvement
- Cross-functional communication
- Cross-functional collaboration
- Documentation and reporting
Licensescertificatesaffiliations
- Certification, Project Management Professional (PMP), Project Management Institute, USA
- Certification, Six Sigma Green Belt, ICON (formerly PRA Health Sciences), USA
- Certification, Internal Auditing for ISO 90001:2000, USA
- Certification, Understanding ICH/GCP Compliance Workshop/Conference, USA
- Affiliate Member, American Society of Quality (ASQ), USA
Professionalpublicationspresentations
- Unifying Quality Management, Veeva World Summit, 09/01/19, Philadelphia, New Jersey
- Evolution of The PRA Health Sciences Quality Management System, ASQ World Conference, 05/01/15, Nashville, Tennessee
- Creating and Maintaining Regulatory Complaint Standard Operating Procedures, Georgetown University, 08/01/01, Washington, DC
- SOPs in Clinical Research- Standardizing Optimizing and the Latest Thinking, Georgetown University, 04/01/02, 07/01/03, 09/01/04, 07/01/06, Washington, DC
Timeline
Senior Manager, Quality & Compliance
ICON Clinical Research
06.2023 - Current
Principal Process Analyst
ICON Clinical Research
04.2017 - Current
Manager, Quality & Compliance
ICON Clinical Research
04.2017 - 06.2023
Process Analyst 3
ICON Clinical Research
10.2009 - 04.2017
Process Analyst 2
ICON Clinical Research
07.2007 - 10.2009
Process Analyst
ICON Clinical Research
08.2005 - 07.2007
Technical Writer 2
ICON Clinical Research
05.2004 - 08.2005
Global Standard Operating Procedure (SOP) Administrator
ICON Clinical Research
07.1997 - 05.2004
Undergraduate, Bachelors - English
University of Virginia
Undergraduate, Associates -
Piedmont Virginia Community College
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