Donna Little
Lichfield,Staffordshire
Summary
An established Clinical Operations leader with 30 years’ clinical research experience, including 10 years in senior leadership roles, motivated by improving outcomes for patients and building high-performing, engaged teams. Proven success leading country, regional, and global Clinical Operations functions across full-service, start-up, and FSP models within cross-functional matrix organisations. Highly focused on regulatory compliance and inspection readiness, with a track record of driving process improvement, technology adoption, and innovation to enhance quality and accelerate delivery timelines. Recognised for developing talent, strengthening site engagement, and improving operational efficiency while consistently meeting budgetary goals.
Overview
30
30
years of professional experience
Work history
Vice President, Clinical Network
Fortrea
UK
2024.04 - Current
- Accountable for Fortrea's global clinical operations and start-up team of >4000 employees
- Responsible for Clinical Network P&L with $300M annual revenue and budget management
- Partnering cross functionally to identify and drive project, site and patient outcomes through identification of efficiencies, accelerated milestones maintaining highest quality and regulatory standards
- Alignment with QA for regulatory compliance, driving quality outcomes and process improvement
- Implemented strategic resource management for assurance of supply aligned to book of business
- Implemented employee engagement, talent development and retention country plans
- Establish training academies, core competency frameworks to support role, individual and therapeutic expertise
- Proactive commitment to technical innovation, as designated business partner
- Maintaining country expertise to drive strategic country and regional growth
- Proactively identify and support business opportunities, networking with internal and external stakeholders
Global Head Clinical FSP
Fortrea
UK
2023.11 - 2024.03
- Responsible and accountable for global team of > 2500 Clinical FSP employees
- Improved financial performance and growth of Clinical FSP
- Participate and lead strategy for RFPs on behalf of Clinical FSP
- Partnered with Alliance leads to enhance client delivery within regions and globally
Snr Director Clinical FSP, Region Head
Fortrea
UK
2019.01 - 2023.10
- Responsible and accountable for team of > 1000 Clinical FSP employees across 15 European countries
- Improved client satisfaction through operational excellence including delivery of KPIs, quality and resource allocation
- Partnered with business development to win new business
- Partner with cross functional leadership for operational success, in-country team engagement, development and retention
Director, Country Head UK & Ireland
Fortrea
Maidenhead
2015.07 - 2018.12
- Accountable for delivery, quality and of Clinical Operations, Start-up and FSP team in UK & Ireland
- Development and execution of country quality plans delivering on country quality metrics aligned to country regulations
- Team engagement and retention strategies, ensuring assurance of supply for project teams and optimized team utilization
- Supported optimization of profitability with on-time delivery, through productivity and in-scope activity
- Monitor cost overruns, including headcount growth, partnering with cross functional leaders on remedial strategies
- Supervised staff training programmes with focus on skill enhancement.
Snr Manager, Clinical Operations
Fortrea
UK
2012.04 - 2015.06
- Performed recruitment and Line Management for client and Clinical Operations CRA/CPA/Start-up team
- Designated company representative at industry meetings: cCOG, Cogent expert panel for development of CRA gold standards
- Development and implementation of CRA performance measures
- Performed on-site quality oversight visits
- Implementation of first Intern program within UK Clinical Operations
- Client relationship management
- SOP review
Clinical Project Manager, FSP
Fortrea
UK
2011.08 - 2012.03
- Implementation, quality oversight and successful delivery of study protocol to client specifics and requirements
- Ethics & regulatory submissions
- Budget and milestone management
Snr Clinical Research Associate
Fortrea
UK
2004.10 - 2011.07
- On assignment to clients in FSP model
- Perform all aspects of study start-up, site management & monitoring
- SOP, protocol amendment- and PIS/ICF author
- Project management assignments
Country Project Manager
Imro Tramarko
UK
1999.07 - 2000.10
- Project manager for phase IIIb UK multicenter study; Budget management, Maintenance through to study closeout
- Monitoring visit report review and approval
- MREC update reports
Clinical Research Associate
Imro Tramarko
UK
1996.09 - 1999.06
- Perform all aspects of site management & monitoring
- Adhered to ICH-GCP guidelines throughout every phase of clinical trials
- Collate LREC submission and updates
- Trained junior staff members, facilitating their professional development
Education
Bachelor of Science - Biochemistry
The University of Sheffield
Sheffield 1992/1992 - 1995/1995
Skills
- Leadership expertise
- Driving operational excellence
- Cross-functional, multi-national team management
- Executive decision-making
- Strategic planning
- Financial acumen and management
- Patient & Site -Centric approach
- Strong scientific acumen
- Broad therapeutic experience
- Global Clinical trial regulations
- Quality oversight and process improvement
Timeline
Vice President, Clinical Network
Fortrea
2024.04 - Current
Global Head Clinical FSP
Fortrea
2023.11 - 2024.03
Snr Director Clinical FSP, Region Head
Fortrea
2019.01 - 2023.10
Director, Country Head UK & Ireland
Fortrea
2015.07 - 2018.12
Snr Manager, Clinical Operations
Fortrea
2012.04 - 2015.06
Clinical Project Manager, FSP
Fortrea
2011.08 - 2012.03
Snr Clinical Research Associate
Fortrea
2004.10 - 2011.07
Country Project Manager
Imro Tramarko
1999.07 - 2000.10
Clinical Research Associate
Imro Tramarko
1996.09 - 1999.06
Bachelor of Science - Biochemistry
The University of Sheffield
1992/1992 - 1995/1995