Life Sciences - IT Management Consulting Services

Co-Author & Programmer of two patented EMR products: SIMECC and DOCUMEDGIL• Conceptualized and developed an Electronic Medical Record (EMR) system, aligning with SOAP methodology to enhance the efficiency of capturing patients' medical histories. In parallel, the systems method guides the physician with a user-friendly interface, facilitating ease of use and documenting treatments for various pathologies presented by patients.• Developed several clear-cut reports for patients and health entities that aid in understanding the staging of the patient pathologies' billing needs and provide a transparent roadmap for the treatment journey.• Successfully commercialized the software across Mexico and currently provide ongoing support to several clinics, hospitals, and private practice physicians who utilize it with patients daily.

Responsible for leading Enterprise Systems Deployment Management projects (LIMS, HR ATS, IT Documentation, HR Performance Management System, etc.), including business analysis, vendor selection and management, testing, training, and implementation. Led IT efforts to commission 3 new sites, site remodels, retrofitting, and consolidation. ▪ Led multiple projects within the IT org to support cross-functional teams at Seres through SER-109 (VOWST) BLA filing, VOWST FDA approval, and FDA audits.• Led efforts with internal R&D and Leadership teams to build requirements, select vendors, and implement a new LIMS system. This significantly improved clinical study and sample management for the animal care facility team and data gathering and organization for the data analytics department.• Developed and drove the Get Healthy program, a strategic initiative to stage systems and infrastructure status across multiple departments, which provided a roadmap for continuous improvement and appropriate resource allocation. • Led IT efforts to commission three new sites, three remodels/retrofitting, and two consolidations of sites. This included infrastructure budgeting, project value engineering, IT Infrastructure design, third-party vendor bidding and management, equipment and materials procurement, and the on-site buildout team coordination and management.

Managed and oversaw operations of Champions IT team of six. Held direct accountability for multiple application systems, including Salesforce, Office 365, AWS, Azure, etc. Responsible for data analysis, efficiency analysis, and performance metrics. Supported Champions LIMS by enhancing a wide range of functions.• Improved cohort randomization methodology of animals in LIMS, resulting in increased efficiency and fewer manual interventions for project managers.• Grew IT Team from three to seven people, including hiring, onboarding, supervising, and evaluating team members. This enabled improved coverage to address failures and increased support for software development efforts.• Led IT project lifecycle, including planning, budgeting, testing, validation, documentation, training, deployment, acceptance, and maintenance. • Communicated and negotiated process improvements/updates/ timelines with Senior Management while maintaining constant and effective communication with R&D, IT, Project leadership, Biostatistics, Finance, Medical Affairs, Clinical Operations, Lab Ops, Business Development, and Marketing team members.• Managed and directed an outsourced software development team, including testing, implementation, change control, and developing internal SOPs to define and document new processes.• Provided continuous support of lab equipment, data analysis, and report development to all teams and departments.• Developed and implemented complex reporting and data warehouse to better streamline operations.

Hired to ensure proper technology operations management, including establishing IT policies and systems to support enterprise-wide growth and needs.• Grew IT Team from one to three people, including hiring, onboarding, supervising, and evaluating team members.• Overseeing the management of IT consultants, technology vendors, and service providers' management, which involved scheduling, delegating workload, and adjusting staffing as necessary.• Acted as the non-scientific member of the IACUC Committee.• Supervised the outsourced software development team, managing tasks such as testing, implementation, change control, and establishing new PM and Laboratory team processes. This allowed for shorter processing times, reduced human data entry errors, and better data analytics.

Led IT infrastructure, Software packages, and systems and lab equipment integration projects, improving communications, processing times, data accessibility, and data management.• Managed all IT infrastructure and enterprise software projects, both internal and external, for Neximmune's administrative and laboratory teams, ensuring seamless execution and alignment with organizational requirements and objectives while carefully managing third-party vendors and internal budget.• Established robust help-desk support processes and thorough team training to optimize efficiency and proficiency in addressing technological challenges.• Supervised overseeing IT software, hardware, and laboratory supplies, ensuring optimal relationships and delivering high-quality resources to support Neximmune's operational excellence.

Joined the team to re-design and improve Noble’s clinical trial database system and its usage throughout the stages of preclinical research, including vivarium management, Animal care facility task scheduling, documentation, and reporting. All this while using an Agile Software Development methodology and the appropriate change control processes.• Spearheaded gathering and dissecting project requirements for data entry, validation, extraction, and financial modules. Translated these requirements into actionable project items and tasks, fostering systematic and efficient project execution. This effort significantly improved user experience and provided data entry guardrails, minimizing data entry errors.• Orchestrated the comprehensive management of sophisticated database design, modeling, and documentation processes for clinical trials, ensuring precision and adherence to industry standards.• Implemented refined improvements in existing and newly created data capture modules, using a careful approach to boost effectiveness and accuracy in data capture procedures.

Hired to support and expand IT infrastructure at the company HQ in Rockville, Maryland. A progression of responsibilities led to managing research and analyzing potential novel and early-stage medical devices for commercialization in Mexico and Latin America.• Conducted extensive market research and meticulously analyzed opportunities within the medical devices sector in Mexico to identify critical trends, potential niches, and market dynamics. This led to a list of selected “candidate” devices to be reviewed further by Senior Leadership for possible registration, FDA approval, and commercialization in Mexico and Latin America.• Generated comprehensive reports based on the latest research findings and market insights, presenting these insights to C-Level management for informed decision-making and strategic planning.• Nurtured and managed relationships with strategic partners and manufacturers (local and international), fostering collaborative partnerships to enhance the organization's position in the medical devices market and ensuring seamless communication between parties.

Supported and developed firmware for the Commercial Vehicle Group• Engineered and crafted sophisticated Embedded Linux Virtualized Software tailored specifically for Commercial Vehicle Clusters, including the design of software solutions to optimize the performance and functionality of commercial vehicle instruments.

Conducted hardware and software R&D efforts for various modules across diverse projects, encompassing telemetry devices, GPS location/tracking systems, and telecommunication devices.• Directed firmware development for industrial water telemetry platforms, leveraging advanced 3G technology to enhance data transmission and monitoring capabilities.• Completed the meticulous development of firmware for a keychain and on-vehicle platform, seamlessly integrating GPS, Bluetooth, Wi-Fi, and 4G technologies tailored for enterprise geofencing and tracking applications.• Managed, documented, and reported test plan procedures and conducted thorough functionality validation for a diverse range of developed devices, ensuring the reliability and performance of each technological solution.

Led and promoted the advancement of technological solutions focusing on precision and compliance within the medical device industry.• Successfully designed, implemented, and validated Graphic User Interfaces (GUI) for medical device applications on mobile devices.• Developed a robust telecom protocol tailored for a medical device, ensuring efficient and secure communication.• Embedded and deployed the communication protocol to a cellphone device, optimizing connectivity and functionality.• Engineered and implemented a server application that provided essential services to medical device end-users on their mobile devices, enhancing overall user experience and accessibility.

Led the design and development of hardware, firmware, and software for medical devices.• Completed the final design phase of a cost-effective glucometer, securing approval from a reputable biomedical devices firm in Mexico.• Designed, programmed, and built a functional prototype of the low-cost glucometer, showcasing practical application and feasibility.• Conducted extensive research on non-invasive glucose measurement techniques, contributing valuable insights to the field.• Methodically tested and compared conventional glucometers with the newly developed low-cost alternative, demonstrating its effectiveness and reliability.

Led the design and development of hardware, firmware, and software for medical devices.• Engaged in impactful research and development focused on digital pulse oximetry, enhancing knowledge in the electronic medical device arena.• Designed hardware, firmware, and interface for a functional prototype of a pulse oximeter, highlighting practical proficiency in the development of medical devices.• Conducted R&D initiatives in handheld portable ECG devices, contributing to the innovation and improvement of this medical technology.