Louise Spencer
Summary
Accomplished professional with extensive expertise in clinical trial management across Phases I-IV, ensuring ICH GCP compliance and excellence in team leadership. Demonstrates proficiency in strategic planning, budget management, and global regulatory knowledge, driving process development and SOP writing to optimise project planning and KPI delivery. Committed to quality management through effective issue resolution, risk management, and audit participation. Career focus on enhancing customer satisfaction through innovative problem-solving and creativity.
Overview
1
1
Certification
11
11
years of professional experience
Work history
Senior Clinical Manager
2021.03 - 2026.07
- Senior Clinical Operations Leader | Acting Head of Department | Global Clinical Delivery | Patient-Centric Research | Phase I-IV Clinical Trials
- (Performing head-of-department duties following restructuring, including strategic planning, cross-functional leadership, and resource allocation.)
- Acting Head of Department following organisational restructuring, accountable for strategic planning, operational governance, and departmental leadership.
- Directed global clinical operations across North America, LATAM, Europe and APAC, overseeing delivery of multiple clinical studies and managing cross-functional teams ensuring compliance with GCP, ISO standards, and regulatory requirements.
- Partnered with executive leadership to define organisational strategy, drive revenue growth, and oversee P&L for international projects.
- Implemented scalable operational frameworks, optimizing resource allocation and improving efficiency across cross-functional teams.
- Championed risk management initiatives and audit readiness, and site and patient engagement initiatives
- Key Achievements & Responsibilities:
- Strategic Leadership: Defined global market entry strategy for Home Health services across North America, LATAM, Europe, APAC. Identified niche markets and implemented innovative service offerings.
- Clinical Delivery / Operational Excellence: Established GCP-compliant SOPs, ISO standards, and quality management systems; led pilot projects to embed new services and ensure scalability.
- Global Team Development: Built and managed cross-regional team, delivering mandatory training programs and fostering culture of compliance and performance.
- Technology Integration: Collaborated with technology teams to design and implement digital platforms and system extensions supporting virtual trials and home nursing services.
- Courier Vendor Management: assessed vendors and ensured robust partnerships for reliable service delivery.
- Regulatory & Compliance: Registered services with regulatory bodies, maintained audit readiness, and managed CAPAs to uphold quality standards.
- Client Engagement: Delivered presentations to audiences at investigator meetings; acted as subject matter expert in home nursing during client meetings and industry events.
Senior Clinical Manager
mdgroup
Bracknell, Bracknell Forest
2025.03 - Current
- Supporting and assisting and deputizing the Head of department for the complete operational set-up and delivery of Patient Services projects.
- Accountable for operational setup and delivery of services, ensuring compliance with ICH-GCP and local regulations.
- Led line management of Clinical Managers driving team development and resource allocation.
- Partnered with Business Development and Proposal teams to support strategic growth, accurate budgeting, and client engagement.
- Oversaw quality assurance, SOP development, and risk management to maintain regulatory compliance and service excellence. Training the department as required
- Delivered training programs for internal teams and external healthcare providers; supported onboarding and mentorship initiatives.
- Acted as key client liaison, presenting solutions and ensuring patient-centric service delivery across global projects.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Reviews research protocols to identify and coordinate training and education requirements for clinical trials sites, and suppliers per protocol and GCP Principles.
- Takes the lead on initiating problem-solving measures as it relates to on call team, and management of on call partners for Patient issues
- Review audit reports, complaints, initiating corrective and preventative action to ensure best practice as it relates to sites and suppliers.
- Ensure that clinical competency assessments and study specific training has been completed for the sites, Healthcare providers and nursing suppliers.
- Collaborates with Supplier and Procurement Manger to build a quality global supply chain for equipment supplies
Clinical Country Lead
Medical Research Network
Milton Keynes, Buckinghamshire
2018.02 - 2025.03
- Managed scheduling and delivery of Home Trial visits, ensuring compliance with protocol windows and nurse competency. Managed any issues during visits.
- Led nurse recruitment, onboarding, and license verification; assigned resources per patient needs and budget constraints.
- Provided training, observational support, and issue resolution, including re-training and risk management.
- Oversaw documentation, sample preparation, and logistics for home visits; adhering to GCP and safety standards.
- Monitored and reported Serious Adverse Events, monthly metrics, and operational performance to stakeholders.
- Approved nurse timesheets and agency invoices, maintaining cost control and compliance
Research Nurse Manager
Medical Research Network
Milton Keynes
2015.06 - 2018.02
- Managed global clinical trials (Phase I–IV) for Home Trial Support, acting as clinical lead and subject matter expert.
- Developed homecare processes with sponsors/CROs and ensured compliance with ICH-GCP and country-specific nursing codes.
- Led nurse recruitment, training programs, and creation of training materials to maintain high standards of care.
- Oversaw trial setup to close-out, including ethics submissions, risk management, and KPI delivery.
- Presented at Investigator Meetings and collaborated with sites and sponsors to ensure protocol adherence.
- Implemented policies and processes to optimize efficiency and patient safety; monitored quality metrics and nurse performance.
- Conducted data quality checks, raised DCFs, and provided corrective training where needed.
Education
MRes - Clinical and Experimental Medicine
University College London
LondonShort Course - Planning & Managing Clinical Trials
Oxford Brookes University
Oxford, Oxfordshire09.2008
Graduate Certificate - Practice Paediatric Intensive
London South Bank University
London, ENGBachelor of Arts - Nursing (Child Branch)
Buckinghamshire College
Chalfont St PeterSkills
- Clinical trial experience (Phase I-IV)
- ICH GCP compliance
- Team leadership & Training/Mentoring
- Strategy and Planning
- Performance metrics
- Customer focus
- Strategic planning
- Budget management
- Global regulatory knowledge
- Process development and SOP writing
- Project planning and KPI delivery
- Problem solving and creativity
- Issue resolution and quality management
- Risk management
- Audit and inspection participation
Certification
NMC Pin Number: 96J1355E
References
References available upon request.
Timeline
Senior Clinical Manager
mdgroup
2025.03 - Current
Senior Clinical Manager
2021.03 - 2026.07
Clinical Country Lead
Medical Research Network
2018.02 - 2025.03
Research Nurse Manager
Medical Research Network
2015.06 - 2018.02
Bachelor of Arts - Nursing (Child Branch)
Buckinghamshire College
Graduate Certificate - Practice Paediatric Intensive
London South Bank University
MRes - Clinical and Experimental Medicine
University College London
Short Course - Planning & Managing Clinical Trials
Oxford Brookes University