• Provide overall leadership in the planning, management, and execution of clinical trials, aligning operations with company objectives and regulatory requirements. Responsible for ensuring clinical operations meet quality standards, compliance, and timelines.• Spearheaded the creation and implementation of the company’s QMS from the ground up, including developing all processes, policies, and SOPs. Established risk evaluation and mitigation tools to manage operational and quality risks effectively.• Developed and managed comprehensive study budgets from inception through close-out, ensuring alignment with financial and operational goals. Monitored and tracked budgets throughout the study lifecycle, ensuring cost control and optimization.• Directed company-wide resource allocation, ensuring the optimal deployment of personnel, technology, and operational assets across multiple clinical trials. Balanced workload distribution, ensuring efficient use of resources while maintaining project quality and timelines.• Managed relationships with sponsors, vendors, and key stakeholders, ensuring high service delivery standards. Oversaw vendor/contractor qualification, performance evaluation, and compliance with contract terms.• Led, mentored, and managed clinical operations teams, fostering a culture of growth, collaboration, and accountability. Provided performance reviews, guidance, and professional development opportunities to ensure high performance and career progression within the organization.

• Managed the day-to-day operations of multiple clinical trials, ensuring seamless execution from initiation to close-out. Developed detailed project plans, monitored progress, and proactively addressed challenges to meet study timelines and regulatory requirements.• Led the development and oversight of project-specific budgets, ensuring alignment with financial objectives. Negotiated vendor contracts and tracked spending, ensuring cost control and compliance with project timelines.• Managed vendor selection and performance, ensuring they met quality and contractual standards.• Acted as the primary liaison between sponsors and internal teams, providing timely updates on project milestones and addressing any concerns.

• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordance with GCP, all applicable regulations, and SOPs.• Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives.• Develop and execute protocol amendment roll-out to 70 international study sites.• Lead cross-functional protocol impact assessment team to update all study documents in preparation of protocol roll out.• Determine clinical trial resources and set priorities for projects.• Lead first PILOT program to implement SCRUM methodology into the TVH business unit.• Partner with cross-functional team to implement and execute a recruitment initiative targeting low enrolling sites and increasing overall study enrollment by 50%.• Achieved internal 2023 study enrollment goal 6 months early.

• Serve as Project Manager for post-market study with 10+ sites, facilitate site identification, site and vendor qualification, and startup meetings.• Lead team meetings, provide project updates, delegate necessary activities, and conduct follow-ups with team members on action items• Support the development of protocols, informed consent forms, case report forms (CRFs), and study plans.• Review monitoring reports prepared by study monitors in adherence with SOPs and study plans. • Assist in the planning and execution of Sponsor and Site BIMO audits. • Mentor junior team members during the onboarding process, including training on new and existing processes, and dissemination of cross-trial information.• Forecast multiple study budgets for the finance department, develop and use tracking tools to track actual costs, monitor and manage the status of the budget, and incorporate cost saving initiatives. • Collaborate with cross-functional groups to identify opportunities, develop solutions, and improve process efficiency to meet study deliverables.

• Manage start-up, maintenance, and close-out of clinical studies.• Perform onsite and remote monitoring visits to verify study procedures, regulatory documents, and ensure data quality.• Assist in analyzing trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in collaboration with management• Maintain clinical study files to ensure compliance with internal procedures and applicable country-specific regulations.• Perform end to end clinical equipment management including procurement, placement, and maintenance. Negotiate reduced rates with vendors and maintain necessary warranties based on contractual obligations. • Develop, manage, and execute site payment procedures across multiple studies. • Key early contributor to the rapid development of in house COVID-19 team based on company initiative. Assisted in developing a company protocol and creating tracking and intake tools used by the team.

• Manage a team of 5 CRA’s and 2 CTC’s, while providing clinical guidance and support on 77 international study sites and all ongoing study projects • Develop and execute plan for roll out of updated protocol to 77 study sites in first month • Design and development of clinical study documents while collaborating with cross-functional team members • Provide project updates on study milestones and goals to senior leadership weekly, adjust goals and assignments of study team to meet milestones • Preside over team meetings, conduct follow-ups with team members on action items• Develop and manage distribution of study recruitment materials and study website • Create study eTMF and affiliated guidelines to ensure maintenance of clinical project files and compliance with internal procedures, and applicable country-specific regulations • Prepare and submit study/site level regulatory documents for local and government regulatory bodies• Identify, build, and leverage effective relationships with cross-functional project teams, field personnel, investigators, site coordinators, CRO’s, and outside vendors

• First CRA on team to gain Health Canada approval and first to enroll an international site • Drove study startup and maintenance for 20+ sites across multiple studies while successfully attaining timeline goals• Negotiated site informed consent form edits while ensuring document was compliant with internal SOP’s and applicable country-specific regulations• Planned and executed study training, startup, and collaborative meetings with investigators and coordinators• Preparation of study start up activities, collaborating with the monitoring team to coordinate on-site qualification, and study initiation at investigator sites as necessary to ensure study requirements were being fulfilled• Provided project updates, participated in work streams and process improvement initiatives

• Expanded clinical research subject pool by ~300% in one year, resulting in exponential increase in revenue produced by the research department • Budget and contract negotiation with Sponsors and CROs, evaluated and negotiated ongoing contracts• Developed and executed advertising concepts for subject recruitment• Managed and monitored the progress of 12+ clinical research studies with over 150 participants • Responsible for researching feasibility/financial benefit of prospective clinical trials, presenting report to Principal/Sub Investigators and Research Director, and determining whether to pursue them • Executed FDA/IRB regulatory reports to gain/maintain compliance • Aided in the planning of studies by identifying the needs of the sponsor, composing study documents and SOP’s necessary to meet those needs • Completed all aspects of study initiation, coordination, and close out• Ordered and maintained investigational product and all study specific supplies for each research trial• Responsible for running studies within budget and maintaining study specific revenue records

• Evaluated patients for developmental baseline using the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)• Collaborated with director to design programs, develop protocols, and set in place standard operating procedures to increase desired or decrease undesired behaviors in patients.• Executed program design until patients reached established developmental milestones• Tracked the results of all programs using daily data collection, Excel, Pivot Tables• Ensured proper data management to maintain quality systems• Analyzed research data after each session and when trends appeared to improve and adjust programs, used lessons learned to adjust for past program outcomes and improved efficiency of upcoming trials• Met with potential clients and participated in proposals, explained programs being used and benefits to patients based on current milestone assessment• Responsible for training and developing new staff as part of mentoring program• Managed client relations while maintaining communication to resolve issues in scheduling, program results, and program deliverables