Hassan Raza
Ilford,Essex
Summary
Accomplished clinical research professional with over 10 years of experience in the Clinical sector. Led teams and optimised Trial Master File systems to ensure compliance and inspection readiness. Developed quality-focused processes and innovative solutions, advancing clinical trial efficiency and quality aligned with organisational objectives.
Overview
15
15
years of professional experience
3
3
years of post-secondary education
Work history
Associate Director TMF Compliance
Adaptimmune
Oxford, Oxfordshire
2024.01 - 2026.02
- Delivered enterprise-wide leadership and subject matter expertise in essential documents, records management, and eTMF, while embedding a strong culture of training, continuous learning, and compliance.
- Established and embedded an inspection-readiness mindset across TMF Compliance and contributing functions, ensuring sustained TMF completeness, accessibility, quality, and regulatory compliance.
- Functioned as Global Process Owner and eTMF Business System Owner, created quality documentation, led user feedback initiatives, and coordinated direct vendor engagement.
- Scaled and strengthened the TMF Compliance group during company re organisation, significantly increasing team capacity and operational effectiveness.
- Advanced oversight capabilities by enhancing KPI monitoring, quality checks, gap assessments, and targeted operational reporting to surface risks and improvement opportunities.
- Led strategic eTMF enhancements and managed services optimisation, aligning off-the-shelf platform capabilities with Adaptimmune’s clinical trial needs.
- Provided hands-on inspection support, overseeing quality control activities and managing electronic document requests end-to-end.
Manager TMF Compliance
Adaptimmune
Oxford, Oxfordshire
2022.10 - 2023.12
- Established and achieved TMF compliance objectives while leading and developing TMF Managers and Clinical Quality & Compliance Specialists.
- Championed TMF strategy in support of Adaptimmune clinical trials and the continued scale-up of the TMF Compliance function.
- Standardized TMF Manager activities through robust processes and partnered with Clinical & TMF Compliance leadership to increase compliance visibility and optimize eTMF utilization.
- Collaborated with IT and Clinical Operations to implement TMF/CTMS governance and expand eTMF capabilities, including expected document frameworks, milestone tracking, and inactive study closure.
- Strengthened quality through a formal completeness review process, updated QC guidelines, and oversight of external TMF mapping, migrations, and vendor-managed eTMF environments.
- Provided subject matter expertise in essential documents, records management, and the eTMF system while leading departmental metrics reviews to drive alignment and transparency.
- Prepared TMF teams for FDA BIMO inspection through targeted training and mock remediation.
TMF Manager
Adaptimmune
Oxford
2022.07 - 2022.09
- Managed the TMF for assigned T-cell studies and monitored their overall health and completeness.
- Led TMF quality review processes and trained team members on best practices.
- Worked proactively with the Study Conduct Team to ensure timely submission of all Essential Documents and resolution of quality issues.
- Created reports to monitor audit/inspection review activities and quality control in TMF.
- Crafted metrics to assess TMF health across all Adaptimmune studies.
- Identified TMF gaps and inspection risks and communicated necessary actions.
- Analyzed study-specific trends/gaps and metrics to ensure prompt resolution of deficiencies to improve quality of the TMF.
- Initiated start-up activities including the development of TMF Plan and TMF Index.
- Partnered with IT to identify priorities for systems provider resolution.
- Mentored colleagues on eTMF system processes and capabilities.
- Lead cross-functional trainings on business processes around Clinical Document Management, Trial Master File and eTMF system(s).
Trial Master File (TMF) Lead II
Syneos Health
Farnborough, Hampshire
2018.10 - 2022.07
- Monitored TMF health and completeness through report generation, ensuring inspection readiness.
- Recommended improvements for optimal TMF oversight and developed compliance enhancement plans.
- Verified studies had been properly created and configured within the eTMF platform.
- Presented as TMF Subject Matter Expert at Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Jump Start Camps, and Quality Finish Camps.
- Trained internal & external team members on the eTMF platform and delivered project-specific TMF training on video and face-to-face.
- Collaborated with the Project Lead (PL) and Functional Leads (FL) to ensure on-time submission of TMF documentation and to maintain high quality.
- Engaged in project-specific audit/inspection preparations and conduct as well as qualification audits.
- Participated in internal project team meetings and sponsor teleconferences/in-person meetings.
- Provided quality feedback to Project Team, identifying actionable metrics and re-training opportunities.
- Collaborated with the Project Team and TMF Operations Team on timelines for key activities such as TMF Shipment, document submissions/publishing, TMF Export/QC, and shipment to the client.
- Understood contracted scope, timeline, and budget for the TMF and identified any out-of-scope work.
- Presented monthly TMF status, risks, issues and associated actions for assigned projects during the TMF Operations Project Review Meeting (PRM).
TMF Co-ordinator Level 2 (Takeda Embedded)
PRA Health Sciences
2017.03 - 2018.10
Senior Study Support Associate
Takeda Pharmaceuticals
2015.07 - 2017.02
Project Co-ordinator
Medpace
2014.11 - 2015.06
Project Administrator
Retro screen Virology (virology Unit)
2013.12 - 2014.11
Clinical Trial Assistant/ Trainee CRA
Quintiles
2010.09 - 2013.02
Education
Bachelor of Science - Pharmacology
University of Hertfordshire
Hertforshire 2006.01 - 2009.01
Skills
- Change Management
- Enterprise Communication &
- KPI Development, Adoption Metrics &
Dashboard Reporting - Digital Adoption Strategy
- Learning & Training Program
Development - Digital Quality Platforms (WalkMe, Veeva
Vault)
- Project oversight
- Change leadership
- Team development and mentoring
- Leadership
- Knowledge of Veeva Vault
- Stakeholder Engagement
Timeline
Associate Director TMF Compliance
Adaptimmune
2024.01 - 2026.02
Manager TMF Compliance
Adaptimmune
2022.10 - 2023.12
TMF Manager
Adaptimmune
2022.07 - 2022.09
Trial Master File (TMF) Lead II
Syneos Health
2018.10 - 2022.07
TMF Co-ordinator Level 2 (Takeda Embedded)
PRA Health Sciences
2017.03 - 2018.10
Senior Study Support Associate
Takeda Pharmaceuticals
2015.07 - 2017.02
Project Co-ordinator
Medpace
2014.11 - 2015.06
Project Administrator
Retro screen Virology (virology Unit)
2013.12 - 2014.11
Clinical Trial Assistant/ Trainee CRA
Quintiles
2010.09 - 2013.02
Bachelor of Science - Pharmacology
University of Hertfordshire
2006.01 - 2009.01