Amy Hahn, Cppm, Mmis Email & Phone Number

• Support database development, user acceptance testing, data reconciliation, and data reporting activities, and data management documentation • Assist with data systems troubleshooting • Conduct clinical data reviews and support query resolution

United States

Developed database specifications aligned with clinical protocols and case report forms (CRFs). Constructed, validated, and managed clinical databases for multiple studies, while ensuring accuracy and data integrity. Filed all related documents in Trial Master File (TMF) to meet regulatory requirements. Authored data management plans (DMPs) and case report form completion guidelines to standardize data collection. Generated data listings and reports by using advanced reporting tools to facilitate study progress tracking. Delivered database training and guidance to team members and study site staff for enhancing operational efficiency. Contributed to development and continuous improvement of data management processes and procedures to drive efficiency and compliance. Performed project tasks in strict accordance with regulatory guidelines. Assumed clinical data manager duties, including comprehensive data review, when required. Adhered to project timelines, budget constraints, and quality standards, while meeting client expectations. Collaborated with clients, auditors, inspectors, subcontractors, and internal departments to promote project success. Organized meetings with prospective clients by showcasing electronic data capture (EDC) systems through demonstrations. · Retained and optimized database systems for seamless operation and adherence to compliance standards. · Designed and implemented EDC systems for clinical studies across various fields, such as stents, wound care, blood transfusions, nerve stimulation, on-body injectors, IVD, and appetite suppression. · Led creation of reference document for custom XML business logic in iMedNet by collaborating with senior developers to compile and review examples for aiding database developers in writing custom edit checks.

Minneapolis, Mn

Coordinated tasks and developers across multiple projects to ensure on-time delivery and optimal resource utilization. Supervised project teams composed of internal technical resources and client stakeholders by fostering collaboration and effective execution. Interacted with technical teams to define project scope, estimate development timelines, and formulate comprehensive project plans. Managed project plans, while overseeing timelines, scope, and budgets. · Delivered high-quality products and services by assisting with quality assurance testing team. · Guaranteed smooth transitions and successful rollouts by directing deployment of project releases. · Implemented and promoted use of standardized processes among project teams to enhance efficiency and consistency. · Streamlined work management and accelerated release execution across projects via SCRUM and Agile methodologies.

Identified and gathered business requirements by guiding clients in understanding technology solutions tailored to their needs. Developed documentation for requirements, testing, and training to verify accuracy and consistency. Led cross-functional project teams composed of internal technical experts and client stakeholders. Conducted continuous product evaluations during development in accordance with requirements and quality standards. Steered release deployments, ensuring smooth transitions and adherence to deployment schedules. · Optimized performance and functionality by designing custom database schemas for tailored solutions. · Achieved business improvements via strategic planning/process redesign by acting as member of traction committee. · Obtained approval from both development manager and company owner to implement all necessary SOPs/WIs for small company, including drafting documents, incorporating feedback, and creating templates driving efficiency.

Formulated development plans and schedules for client projects in alignment with business objectives and timelines. Supported direct reports by clarifying project objectives and guiding development of action plans. Monitored direct reports' performance by performing regular performance evaluations and salary reviews to foster growth and accountability. Mentored direct reports and other staff by enhancing their technical skills and professional development. Performed all responsibilities associated with senior technical resource specialist role for EDC builds, while focusing on enhancing infrastructure, promoting economic development, and delivering high-quality services across various sectors. · Increased team resources and productivity by assisting projects and tasks to direct reports. · Enabled in defining business requirements for iMedNet EDC system in accordance with client needs and project goals. · Boosted self-esteem and attained performance improvements via development plan for underperforming employee by scheduling bi-weekly meetings, providing constructive feedback and encouragement, and highlighting improvements.

· Maintained internal technical coordination and communication for all client development projects · Coordinated cross-functional efforts to achieve study objectives and goals for all client development projects · Reviewed protocols to match client technical needs with appropriate MedNet services · Reviewed and wrote system requirements and functional specifications· Reviewed and designed case report forms to ensure efficient and thorough approach to website trial architecture. · Developed clinical systems, including: case report forms with validation, user access levels, study reports, and system components· Assisted in test planning, test case creation and test execution on client systems· Responsible for the proper training and communication of all technical functions to the appropriate personnel within the project teams

· Responsible for serving internal and external customers by providing product and service information· Provided excellent customer service to help ensure quality service delivery to our customers with timely resolution and follow-up· Diagnosed and resolve software, hardware, and database problems, and assist with website testing· Responsible for administrative duties that include shipping training materials, data entry, filing, and other supporting duties

Master'S Degree, Management Information Systems

Information Management Concentration GPA 3.97

Graduate Certificate In Project Management

Web Programming Certificate

Web Technologies Certificate

B.S., Technology Management

GPA 3.94

A.A.S., Cad Drafting

Earned four Academic Awards GPA 3.96