Matthew Ransdell Email & Phone Number

- Assigned to the Clinical Informatics Branch (CIB) of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) via contract from BluOmega- Serves as Business Analyst and technical SME for eTMF system working directly with project team internal to NIAID.- Supports installation, configuration, onboarding, and maintenance of eTMF, CQMS, and EDRMS systems as they pertain to Clinical Trials- Gathers and develops documentation to support system validation- Acts as liaison between project team and vendor to ensure software compliance/requirements- Leads internal and external user training- Establishes and maintains internal processes, work instruction, workflows, and other documentation/processes to support enterprise eTMF software

Raleigh, North Carolina, United States

Managed and led teams working through Development and Validation for major andminor updates to Regulatory Applications.Drafted, maintained, and reviewed internal documentation for system validation,standard operation procedures, and job aids.Created and maintained Rollback plans, Fail-Over Procedures, and Business Continuityfor major Regulatory Applications that concerned on-going Tier-1 Projects.Fielded and triaged P1/P2 issues and helped to navigate to resolution within companytimelines/expectations.Authored and reviewed procedure/scripting documentation for validation processes andused those documents to manage project teams and their resources to ensure coveragefor updates.Drafted and maintained user security matrices and databases to ensure end-users hadaccess to restricted and non-restricted items as required for all necessary applicationsand software.Provided best practice insight for business teams as they navigated RegulatoryApplications. Used the knowledge shared by the business teams to then createenhancement requests to be delivered to the Vendor.Investigated and determined root-cause for any and all issues/defects encountered

United States

Personally responsible for the owning and operating of multiple Client accounts asit pertains to their Pharmaceutical and Clinical Research server environments in aSoftware-As-A-Service (SAAS) setting.Organized weekly and bi-weekly meeting cadences with multiple Client teams to assistwith configuration changes, server environment questions, and trouble-shooting of theireTMF and CTMS software platforms.Organized and handled client meetings, client configuration changes, internal meetings,and product updates on a weekly basis that were unique to the team or client I wasassigned.Utilized individual research and self-start techniques to find solutions for client requestswhile working in a remote setting. Was able to determine root cause and troubleshootissues through utilizing internal knowledge base articles, querying help references, andworking cross-department.Wrote test scripts, deployment checklists, and performed configuration changes and UATper SOP in both sandbox and production environments.Wrote scripts to be used with an API to make bulk changes to thousands of data sets at atime. Tested these scripts and trained others on how to perform the same API calls/edits.Assisted in testing and implementing new software updates and then translating thepatch notes into content that could easily be understood and digested by individualsworking in a CRO or Pharmaceutical setting.Worked closely and coordinated with 3 different internal departments to bring qualityservice and software support to client teams.Used JIRA, Zendesk, and Salesforce to keep track of client requests, open tickets,accounts, and project information.

Raleigh-Durham, North Carolina Area

- Create and manage Qlik applications for multiple departments in order to provide in depth analytics and predictions based on data provided.- Created Qlik application for Site ID and Study Start-Up that allowed team members to query Time-to-Open data for specific hospitals in relation to their location, specialty, and doctor database in order to better apply knowledgeable guidance to Clients. This application allowed the department to filter the data in 15 minutes when before it took them nearly a full work day using Excel sheets to query the data.- Created Qlik application for department VP that allowed them to view real-time data visualizations that showed employee bandwidth and workflow so they could better distribute new studies and projects in a more even manner- Developed Qlik application that allowed end-users to query internal databases in order to find study specific information and link it to our doctor database in order to view meshed data points- Performed data review in order to crate metrics and identify data anomalies- Performed Root-Cause Analysis for departments upon request

Morrisville, Nc

• Supported integration and initial adoption of new portal technological system by Novella starting at inception of concept• Maintains portal system in compliance with ICH-GCP, country regulatory requirements and procedures set forth by Novella• Completes both study set-up and site adoption for new studies awarded• Works closely with site personnel for integration of portal system, entry of investigators, and resolution of feasibility, start up, and maintenance procedures• Works with Associates concerning Feasibility Packet development (e.g. programming and UAT [User Acceptance Testing] for eFQ) within the Portal system• Completes system set-up required for regulatory document distribution• Assists with Site-Staff training set-up and implementation within Maintenance phase• Trains both Site-Staff and Internal-Staff in regards to Portal usage, procedure, and navigation• Supports both Novella-Users and Study Site Users with system questions, technical assistance, and troubleshooting• Works closely with developers of Portal in regards to system enhancements, bug fixes, UAT, testing, and system patches.• Perform QA and write Test Cases for Portal System Updates• Contributes ideas and insight to further the development and evolution of Novella’s Portal system• Conducts/Leads Study Kick-off meetings as well as interval study-team meetings as needed• Works closely with Study Site Staff to resolve action items, build a working relationship between Novella and the Site, as well as to assist with any Study related questions and requests.• Documents study challenges and effectively communicated them to my colleagues working within the given Study• Assists other Leads, Managers, and Project Managers with reporting on data within the Portal as needed• Conducts interviews of potential new Novella staff members in accordance with Novella procedure in order to find both the best fit for the position as well as the best fit for the company culture

Raleigh-Durham, North Carolina Area

• Performs necessary administrator duties in relation to Novella Conduit such as:o New User, Trial and Site creation/managemento Internal and Site User support, explanations, site walkthroughso Updating and maintaining study specific information on an as-needed basis• Updates and maintains PI Database contact entries• Create and distribute Feasibility Questionnaires• Fully execute and distribute Confidential Disclosure Agreements (CDAs) for sites• Set up, distribute, and act upon Regulatory Packets within the Study Start Up phase• Runs reports and conducts searches for PI experience in the PI Database• Corresponds with potential investigators regarding study opportunities• Supports PI Database project lead on database improvement and data cleaning projects• Assists ISSC Leads and ISSC Managers with reports and essential documents as needed• Assemble Feasibility, Regulatory, and training packets• Conducts all activities according to appropriate Novella and/or sponsor SOPs• Support Associate with feasibility packet development e.g. UAT for eFQ• Assists with the creation of templates for regulatory documents specific to local and central Institutional Review Board (IRB) / ethics committee submissions• Updates CTMS system as documents are received by ISSC team members• Files documents into ISFs according to study requirements (paper or eTMF)• Assists with, tracking/filing of reportable expedited safety reports and cross reports to sites as needed• Documents study challenges and effectively communicate those to the ISSC Associate, Lead and/or ISSC Manager• Performs other duties as required

Durham, Nc

-Worked as part of a team in Quality Assurance Department-Worked on numerous Stage II and Stage III clinical research contracts garnered from various -Sponsors in the field of Oncology and Central Nervous Systems (CNS)-Began as the individual in charge of coordinating the work-flow for our team of Clinical Specialists.-Took inventory of daily processing every morning and applied work duties to specialists in a balanced manner for their daily processing and intake.-Personally helped to create and implement a new form of work-flow that allowed Specialists to transition from hard-copy processing to digital processing using company's internal network and Adobe software-In 2013 I transitioned to a new team as a founding member for a new Clinical Research partner based out of the European Union. I was part of a select few that was trained on this new protocol as well as the GCP and International Conference on Harmonisation (ICH)-Participated and contributed in various meetings throughout the week that helped to keep a tight-knit team working on strict deadlines for our Sponsors.-Met strict deadlines as set by the FDA and our Sponsors in regards to the processing of Stage II and Stage III Clinical Research Data-Maintained and managed the Central Master Case File Room-File-Room where Clinical Research and Patient Information was stored-I was always a team player and went out of my way to afford my team a comfortable work-flow and stress-free environment . I also participated in numerous company sponsored events to show support for the team and the individuals within

Raleigh-Durham, North Carolina Area

· Worked as a Document Control Specialist in Functional Services Dept· Gathered and condensed/copied files, uploaded files and paperwork into INC network· Prepared documentation for filing in Master File· Helped with upkeep and maintenance of documentation pertaining to on-going research

Raleigh-Durham, North Carolina Area

· Worked with agents on handling money accounts · Handled all aspects of new/existing policy accounts· Contacted customers directly in regards to their policy accounts· Answered incoming calls to assist customers and agent issues

Raleigh-Durham, North Carolina Area

· Worked as an Intern for Global Training Director in the Training Department· Gathered files on personnel and removed out-dated forms· Redistributed personnel files in accordance to new system of document filing· Helped with training room set-up and clean-up in accordance to the order of operation

Bachelor'S Degree, Anthropology

Anthropology degree with concentration in cultural and medical

Bachelor'S Degree, Psychology

Activities and Societies: Soccer, Dean's List, Philosophy Club, Spanish ClubBA Psychology with concentration in Behavior

Education record

Activities and Societies: Spanish Honors Society, BETA, SkillsUSA (VICA)