Recruited to leverage technical, clinical operations and quality background to define and support business transformation efforts including globalization and optimization of the quality management system, identification and implementation of eSource and other clinic automation software, and exploring how elements of the hybrid clinical trial model may serve to streamline early phase research. Executive leadership of the global Quality function and team. Planning, preparation, and hosting of two clean FDA surveillance inspections conducted in Australia.

Promoted to serve as a key member of the global leadership team. Directed the development of systems, practices, and processes to ensure the most safe, effective, and efficient clinical trials, whether decentralized (in-home assessments), virtual (telemedicine assessments), bricks and mortar (on-site assessments), local healthcare network (standard of care assessments), or any hybrid combination. Ensured company’s compliance with all applicable regulatory requirements and standards, worldwide. Developed and maintained external relationships with regulatory officials. Fostered a culture of continuous improvement across the organization. Oversaw sponsor audit and regulatory inspection readiness. Complete QMS oversight, including risk assessments, vendor qualification and management, controlled documents, deviations, CAPAs, change management, and audit programs.Key Contributions:Developed briefing document content and participated in key discussions with FDA Office of Medical Policy officials regarding real world experience and regulatory acceptance of the virtual, decentralized and hybrid clinical trial modelsSupported clients with study design and regulatory submission input in the absence of regulatory guidance on emerging clinical trial modelsLed globalization and organizational growth of 450% over two years while effectively managing major client audit findings to minimal levels

Led sponsor audit and regulatory inspection preparation, execution, and response. Directed the implementation and execution of continuous improvement initiatives and quality oversight measures within the company, such as Quality Management Reviews. Directed the development and ongoing refinement of SOPs company wide. Oversaw system validation activities. Administered the vendor qualification and management system. Planned and conducted internal audits of Science 37 operations. Identified new regulations and guidance, authored related white papers, and lead overall compliance initiatives.

Strategic leadership and oversight of the day-to-day activities of the Quality Assurance department. Responsible for all activities globally involving quality assurance and compliance of internal operations, vendors and investigative sites with applicable regulatory requirements, ICH/GCP, company Policies and SOPs, QA validation activities and compliance training.Key Contributions:Global quality lead for a 3 year, $38M, Phase III, rare disease, full-service, global study with 160+ enrolling sites. Complete oversight, including: CRO and Sponsor operations, auditing, investigative sites and vendors. Hosted the clean FDA surveillance inspection; the drug-device was approved in Sep. 2018Optimized post-acquisition global Quality Assurance function to eliminate redundancies, maximize efficiency and ensure regulatory compliance, including definition and implementation of KPIsPlanning, preparation and hosting of the organization’s first dual regulatory inspection conducted by the EMA and FDA with clean outcome

Executive leadership of Quality Management Systems, Human Resources and Information Technology.Key Contributions:Harmonized the organization’s disparate site/phase I unit and CRO Policies, SOPs, Work Instructions, Handbooks, Job Documents and supporting Forms into one cohesive library of QMS documentsPlanning, preparation and hosting of two clean regulatory inspections – FDA and PMDAImplemented an electronic learning management system to replace manual delivery and tracking of 300+ employee’s training and development-related activities

Planned, directed and coordinated all operations of the organization, including Clinical and Information Technology. Ensured and improved the performance, productivity, efficiency and profitability of departmental and organizational operations through the provision of effective leadership methods and strategies.Key Contributions: Authored and implemented the startup organization’s comprehensive library of Policies, SOPs, Working Guidelines, Handbooks, Job Documents and supporting FormsDeveloped and implemented the organization’s first project delivery metricsFaculty presenter at 3 industry conferences in 2012

Provided tailored solutions to meet clients' clinical, compliance and QMS needs.

Promoted to leverage my Clinical Operations and Information Technology background at the organizational level to create synergy between people, process and technology. Oversaw the design and continued development, management and evaluation of the Quality Management System. Change agent for strategic objectives; facilitate organizational buy-in and lead key stakeholders toward achievement of goals. Ensured training compliance for all functional areas and roles. Facilitated the development and improvement of processes through review and management of procedure deviations, change requests, quality control and audit findings, and training feedback. CAPA and audit trend analysis. Assured proper planning, hosting and follow-through for regulatory agency, prospective/existing client and supplier audits. Key Contributions:Implemented a holistic model for quality management at the organizational levelServed as Product Manager for the planning, selection and implementation of an electronic document management system, including CAPA and training modulesLed the post-acquisition harmonization and gap remediation of the global library of Policies, SOPs and Working GuidelinesActive contributor in the development and finalization of the Metrics Champion Consortium (www.metricschampion.org) industry-standard Clinical Trial Performance Metrics

Promoted to provide hands-on strategic leadership to improve quality, profitability and ensure adherence to project scope, timelines, deliverables and budget requirements in the functional area primarily responsible for site recruitment, selection and start-up, including the creation, collection and maintenance of all essential documents, trial master files and related matters such as IRB/Ethics Committee approvals. Strengthened partnerships with all Clinical functions. Ensured appropriate position requirements and oversaw hiring, training and mentoring of associates. Partnered with functional area Managers to set schedules, forecasts and staff planning, budgeting and metrics implementation and tracking. Collaborated with the Business Development team in budget and proposal preparation providing input, successful management strategies and a qualified project team. Developed materials for and participated in capabilities presentations and industry conferences. Key Contributions:Pulled work down from Project Management level to lower compensated positions to increase project and corporate profit marginsLed the division to unprecedented Trial Master File quality within 4 months of takeover, receiving no audit findings from a major Sponsor during a 3 day, 3 auditor auditImplemented an accelerated onboarding and training process for the division, reducing the time lapse between staff being hired and performing billable work

Hired to address operational inefficiencies, including: lagging systems development timelines, systems instability and declining customer satisfaction ratings. Facilitated the course and execution of the design, development, integration, implementation and support of all enterprise information systems, including: voice and data communications, wireless services and the Virtual Private Network, software applications, and all other infrastructure components used to conduct and support the business operations and processes. Actively participated as an integral member of the Executive Leadership Team, working in partnership to support the organization’s long-term strategy and goals, including alliances, joint ventures and other partnerships. Managed and mentored the Software Development, Network Operations and Support Services team members, providing guidance in establishing and meeting relevant functional area goals, objectives and timelines.Key Contributions: Led the division to record levels of customer satisfaction (97% +) and system uptime (99% +)Restructured the Software Development team to reduce costs and accelerate productivity, delivering a robust clinical trial management system in 14 monthsImplemented a proven model to ensure division alignment with the organization’s mission, strategy and goals, and accountability in meeting them