Datchet, England, United Kingdom
Senior business manager with a proven track record in strategic planning and driving global transformation. I am a highly motivated leader with exceptional organizational and interpersonal skills, adept at leading teams through change and achieving successful outcomes. Throughout my career, I have excelled in worldwide operational leadership roles, consistently recruiting and building high-performing teams focused on delivering quality results. With over 30 years of experience in the field, I have a deep understanding of Clinical Development services and have consistently delivered high-quality and cost-effective solutions. My specialties include leading and developing global teams, strategic business planning, driving transformational change, relationship management, people leadership and motivation, process improvement, influencing and negotiation, project management, and information management within the Clinical Development space. I am passionate about driving innovation, fostering collaboration, and achieving measurable impact in the healthcare industry. Let's connect and explore how we can collaborate to drive positive change and achieve remarkable results.
Provide leadership and direction to the board and the organisation. ACDM: "Empowering Excellence in Clinical Data Management"
Responsible for leadership, strategy and operational delivery across 4 regional hubs: China, Eastern Europe, India and LATAM.
Responsible for global leadership and strategy for client-specific customised solutions supporting clinical development
Responsible for global leadership and strategy for client-specific customised solutions supporting clinical development
Responsible for developing and operationalizing flexible outsourcing models to enhance productivity, decrease delivery time and deliver large cost efficiencies for Biostatistics, Statistical Programming, Data Management, Medical Writing services and Clinical Supplies.
Led the development and implementation of strategic programmes aimed at improving the delivery and conduct of clinical studies: Delivered reduced overheads, improved margins and increased customer satisfaction through the project management of multiple cross-functional work teams e.g. risk-based monitoring, rSDV, on/off-site monitoring activities, data processing and SAE processing. Advanced TMF management from the traditional paper collect and file approach to an integrated electronic trial document management system supporting effective study management and ensuring compliance to GCP/ICH regulations. Evaluated the Corporate Quality Management System proposing redevelopment and implementation of a new QMS improving all processes and compliance controls.
Develop strategy and direction that covers all activities across the global data management groups (US, EU and India). Responsible for the implementation and integration of EDC technology across all functional areas and clinical phases. Core member of both the world-wide strategic steering committee that provides strategy and direction to all operational activities and the global Project Review Board that guides the management of all clinical trials.
Re-engineered regional based Data Management departments into a unified global group; implemented a global system architecture and established common standards for data acquisition, data cleaning, database construction and management that enabled global working and data sharing. Realigned data management activities into Therapeutic Knowledge Centres to deliver greater strategic and operational planning which increased productivity and improved Data Managements product delivery.
Developed the direction of the new department that covered structure, competencies, sourcing strategies, systems and business processes required to meet clinical research objectives.