Bernadette McIvor
Armadale,WLN
Summary
Results-driven professional specialising in project management, quality assurance, and risk management. Delivers regulatory compliance and fosters stakeholder engagement through strong problem-solving and organisational skills. Utilises advanced Microsoft Office and AI technologies alongside expertise in CTMS, Power BI, Adobe Acrobat, SharePoint, and Synopsis Clinical to enhance project outcomes.
Overview
28
28
years of professional experience
Work history
Trial Master File (TMF) Lead II
Syneos Health
2021.08 - 2026.01
- Served as Trial Master File subject matter expert, providing strategic oversight for global studies and ensuring inspection readiness.
- Conducted TMF health checks, completeness reviews, and compliance tracking across multiple global projects.
- Delivered project-specific TMF training, procedural guidance, and quality metrics to internal stakeholders and sponsor teams.
- Partnered with project and functional leaders to implement TMF improvement plans and uphold GCP requirements.
- Supported regulatory audits and inspections by presenting TMF status, identified risks, and mitigation strategies.
- Produced regular reports detailing TMF performance, timelines, and quality deliverables.
TMF Quality Project Manager
IQVIA
2016.01 - 2021.07
- Led Trial Master File process oversight as subject matter expert, managing setup, maintenance, and quality control for multiple global studies.
- Directed TMF compliance activities, file reviews, and sponsor deliverables to maintain inspection readiness.
- Facilitated TMF training sessions and contributed to continuous process improvement initiatives.
- Collaborated with functional leads to support client KPIs, forecasting, and performance reporting.
- Mentored junior TMF team members to strengthen capability and elevate quality standards.
Senior Clinical Project Coordinator
IQVIA
2015.04 - 2016.01
- Supported cross-functional project teams with study setup, documentation management, and milestone delivery.
- Coordinated financial tracking, procurement activities, vendor relationships, and study logistics.
- Assisted with project planning, risk mitigation activities, and performance monitoring.
- Ensured compliance with contract scope, standard operating procedures, and quality requirements.
- Performed finance tasks Revenue, billing, invoicing. Backlog.
Senior Clinical Data Coordinator
IQVIA
2007.06 - 2015.04
- Managed documentation and project tracking, ensuring clear communication across clinical studies to meet project milestones.
- Conducted quality reviews and supported audits, contributing to compliance with regulatory standards and best practices.
- Supported project managers in financial tracking, timelines, and resource planning.
- Coordinated internal and client meetings, preparing agendas and materials to facilitate discussions and capture key decisions.
Clinical Data Coordinator II
IQVIA
1998.10 - 2007.06
- Executed data entry and conducted quality control checks in accordance with GCP/ICH guidelines.
- Supported database setup and managed queries for multiple clinical trials.
- Ensured data accuracy, completeness, and compliance with regulatory standards.
Administration and operational support
St Johns Hospital
1997.09 - 1998.10
- Managed information flow to medical staff, supporting effective collaboration and timely decision-making.
- Facilitated communication by addressing inquiries and liaising with departments, enhancing collaboration and information sharing.
- Executed data entry and record keeping with specialist software, ensuring accurate analysis and tracking of results.
Education
HNC - Office Administration
West Lothian College
Bathgate, West LothianAI Technology
Linkedin Learning
2025.12 - 2026.02
Skills
- Project management
- Quality assurance
- Risk management
- Problem-solving
- Organisational skills
- Quality assurance
- Team building
- Communication skills
- Calm under pressure
- Regulatory compliance
- Stakeholder engagement
- Advanced Microsoft Office
- AI Technology
- Advances Technical (CTMS, Power BI, Adobe Acrobat, Sharepoint, Synopsis Clincial)
Timeline
AI Technology
Linkedin Learning
2025.12 - 2026.02
Trial Master File (TMF) Lead II
Syneos Health
2021.08 - 2026.01
TMF Quality Project Manager
IQVIA
2016.01 - 2021.07
Senior Clinical Project Coordinator
IQVIA
2015.04 - 2016.01
Senior Clinical Data Coordinator
IQVIA
2007.06 - 2015.04
Clinical Data Coordinator II
IQVIA
1998.10 - 2007.06
Administration and operational support
St Johns Hospital
1997.09 - 1998.10
HNC - Office Administration
West Lothian College