Elizabeth Mathews

• Develop and implement the global Quality Management Plan with scope of the assignment, which includes planning and executing Quality Management activities
• Managing risk assessment through data review and quality control processes
• Cooperate closely with the relevant business and other stakeholders, support and maintain focus on quality in project delivery
• Provide assistance during audits and regulatory inspections to the teams, in order to extend the support agreed with the business lines as required by the applicable SOPs
• Be the primary contact for Quality Assurance on quality matters.

Training Manager responsibilities

• Leads all training activities within Lifecycle safety and serves as the corporate subject matter expert for the line business assigned.
• Develop, design and implement Project Training plan from initiation, monitor throughout with regular updating of content and maintain quality throughout the lifecycle of a project.
• Ensures Training needs are consistently met for all functional teams.
• Responsible for Training compliance for specific Project and other departments.
• Pioneered in developing and delivering ‘Train the Trainer’ program emphasizing on corporate needs such as adult learning principles (inspired by Malcolm Knowles), ADDIE principles, Instructional Design, 70-20-10 corporate training model, etc.
• Mentor and train Trainers, Managers and Subject Matter Experts in effective development of training content, creation and delivery of trainings.
• Involved in Project Planning, Initiation, Managing and Monitoring Training activities.
• Develop and create Training materials (PowerPoint, Articulate 360 etc.). Supports the development and certification of Training Professionals by leading client and corporate required training

Using Results standard processes and methodology, evaluates learning effectiveness within the classroom through a program of regular observation of Training Professionals and through reviewing their performance data.

• Interpreted clients' needs and introduced services to fit specific requirements.
• Followed all company policies and procedures to deliver quality work.
• Attended training programs to deepen professional skillset and trained associates on existing and new training programs.
• Listened and responded to customer requests and forwarded necessary information to superiors.

• Manage Data Entry project and increased quality of the team from 58% accuracy to 91% accuracy
• Perform daily ICSR and source data review of cases processed by Accenture SER group
• Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives
• Support/promote accuracy, internal consistency, uniformity, collection of metrics data for quality analysis and compliance with regulatory commitments and expectations
• Provide support activities for regulatory inspections, internal audits and/or strategic quality initiatives
• Maintain an understanding of AQuA, ARGUS and case processing activities so as ensure the accuracy of safety data
• Provide mentoring and training for colleagues as necessary, working with TLs/TA leads to provide support across all sites
• Compile Individual Case Safety Report data quality metrics to ensure consistency within cases and correctness of the data relative to the AURG, SJAs and regulatory expectations
• Manage the completion of routine tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses, and corrective action planning with customers as necessary
• Contribute to metrics reporting for all assigned therapeutic area studies
• Work with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations, efficient use of resources and sharing knowledge/best practices
• Support internal quality improvement activities and perform all tasks as assigned by DDQC lead.

• Client Interaction
• Receive, triage, review and process Life cycle safety operational data from various sources on time, within budget and quality standards
• Perform data entry for tracking and Life cycle safety
• Writing descriptive narratives
• Generating queries pertinent to the case
• Assisting with reconciliation, driving case closure and ensuring reports are sent to the client within assigned deadlines
• Perform other duties as directed by the Lead Manager or Functional Manager
• Meet objectives as assigned.

• Execution and Presentation of a detailed Data Management project plan to clients
• Discrepancy Management
• DCF Update & Review
• Raising DCF, Quality Control
• Understands and comply with core operating Procedures and working instructions
• Perform other duties as directed by the Lead Data Manager or Functional Manager.

• Provided emergency surgeries for patients with broken teeth or facial bones, prioritizing both functionality and aesthetics during treatments.
• Communicated about treatment options and accurately relayed information to patients.
• Closely monitored patient comfort during treatments, adjusting tools and medications to uphold best-in-class comfort standards.
• Administered anesthetics and sedatives to control patients' pain and reduce stress for anxious patients during procedures.