Kylie LOTF
Herndon,VA
Summary
Results-oriented Clinical Data Management professional with expertise in data quality control and cross-functional communication. Led process improvement initiatives that enhanced workflow efficiency and client satisfaction. Skilled in statistical analysis and building strong client relationships to achieve successful project outcomes in GLP-compliant environments.
Overview
9
9
years of professional experience
Work History
Supervisor I
Smithers PDS
Gaithersburg, MD
12.2025 - Current
- Led and mentored Clinical Data Management staff across multiple GLP studies to enhance team expertise and project outcomes
- Manage timelines, deliverables, and workload prioritization to meet client deadlines
- Serve as primary sponsor point of contact for deliverables, escalation, and status
- Oversaw QC, reconciliation, DCF/DTA tracking, and final reporting to ensure data accuracy and compliance
- Authored SOPs and implemented process improvements to streamline workflows and optimize efficiency
- Represent DM during internal/external audits and resolve findings
- Partner with QA/PM/Lab Ops to streamline workflows and ensure integrity
- Drive continuous improvement initiatives reducing rework and defects
Lead Clinical Data Manager
Smithers PDS
Gaithersburg, MD
02.2024 - 12.2025
- Led study-level data management including QC review and reconciliation
- Coordinated cross-functional communication, ensuring adherence to study timelines
- Executed DCF review, maintained DTA, and validated data transfers for accurate reporting
- Designed SOPs and trackers implemented department-wide
- Generated trending analytics to enhance study interpretation and decision-making
- Prepared databases and documentation to ensure audit readiness
Clinical Data Management Specialist
Smithers PDS
Gaithersburg, MD
02.2023 - 04.2024
- Performed daily data cleaning, QC, and validation for GLP studies
- Ensured accuracy and completeness of databases, trackers, and metadata
- Corrected missing or inaccurate sample metadata to improve data integrity
- Supported discrepancy tracking (DCF/DTA) and Watson LIMS reconciliation
- Identified process issues and recommended workflow improvements to enhance data management efficiency
- Compiled study metrics and summaries for internal and sponsor review to support decision-making
COVID Testing Program Coordinator
Howard Hughes Medical Institute
Ashburn, Virginia
08.2022 - 02.2023
- Supported COVID testing operations and ensured compliance with testing regulations.
- Report results to the medical director and the state.
- Ensured quality assurance and quality control for laboratory processes to maintain testing standards.
- Compiled and analyzed statistical reports using SharePoint and Lockbox to inform decision-making.
- Resolved issues with the laboratory information management system (LIMS) to ensure smooth operations.
Software Support Tech
Pandemic Response Lab
Rockville, Maryland
11.2021 - 08.2022
- Delivered remote and on-site customer support, troubleshooting software to ensure accurate clinical sample processing.
- Mastered new software and hardware updates, analyzing and reporting issues to enhance system reliability.
- Utilized Confluence documentation and managed Jira ticket service effectively.
- Developed practical skills in navigating and operating multiple laboratory information systems (LIS) and laboratory information management systems (LIMS) to support laboratory operations.
- Developed strong communication skills to convey information clearly to diverse audiences.
- Developed Excel document to collect QC data, facilitating control tracking within QA program.
Medical Laboratory Technologist
Pandemic Response Lab (PRL)
Rockville, Maryland
04.2021 - 11.2021
- Accessioned patient samples for RNA extraction, processed RT-PCR, reviewed results, and released findings within promised turnaround time.
- Daily testing of patient samples, adhering to the laboratory’s quality control policies and SOPs.
- Assisted safety officer by conducting safety inspections and maintaining compliance with safety standards. Handled safety checklists and safety procedures.
- Operate and troubleshoot equipment, including the Felix from Analytic Jena, OT2s from Opentrons pipetting robots, Echos, Mantis, Tempest, Cellario, Beckman, Roche LightCycler, and Apricots.
- Coordinated team support for quality control, documenting activities, calibrations, and maintenance of instruments and procedures.
- Assisted in validating multiplex assays, including STI and respiratory panels, ensuring accuracy and compliance with testing standards.
- Attended all applicable safety training sessions on safety manuals, SOPs, and learned the location and use of all applicable safety equipment.
Clinical Laboratory Technician
Curative
Washington, District of Columbia
10.2020 - 04.2021
- Plated and accessioned patient samples for SARS-CoV-2 Multiplex RT-PCR Assay, facilitating timely testing and reporting.
- Supported Clinical Lab Scientists in RNA extraction and qPCR for COVID-19 testing while ensuring compliance with safety standards.
- Prepared and aliquoted Master Mix using MultiDrop under sterile conditions, ensuring accuracy in testing processes.
- Operated lab equipment, including centrifugation machines and HiRes Workcell, following sterilization techniques and safety protocols.
- Conducted sample assays for quality assurance and quality control, supporting reliability of test results.
Laboratory Technician
GeneDx
Gaithersburg, Maryland
05.2020 - 10.2020
- Executed PCR clinical assays, ensuring high precision and accuracy in results.
- Performed manual PCR, including primer creation, mastermix preparation, and DNA dilution, to support accurate assay development.
- Conducted automated PCR with Hamilton robots to streamline processing time.
Research Assistant
George Mason University
Manassas, Virginia
04.2017 - 09.2018
- Assisted in evaluating efficacy of two Rev-dependent lentiviral vectors in treating SIV-infected Indian Rhesus macaques.
- Conducted and documented experiments independently while adhering to lab protocols.
- Utilized aseptic techniques for DNA and plasmid purification, cell culture, and transfection.
- Performed western blot, gel electrophoresis, and flow cytometry analyses efficiently.
- Utilized time management skills to prioritize tasks in a fast-paced lab environment. to uphold strict lab protocol compliance.
- Worked in a BSL-3 lab environment handling HIV safely.
Education
B.S. - Biology, Computational Data Science
George Mason University
Fairfax, VA12-2019
A.S. - Science
Northern Virginia Community College
Manassas, VA12-2016
Skills
- Data management and quality control
- Cross-functional communication
- Statistical analysis and SOP development
- GLP compliance
- Process improvement
- Client relationship management
- Problem solving
- Attention to detail
- Time management
Timeline
Supervisor I
Smithers PDS
12.2025 - Current
Lead Clinical Data Manager
Smithers PDS
02.2024 - 12.2025
Clinical Data Management Specialist
Smithers PDS
02.2023 - 04.2024
COVID Testing Program Coordinator
Howard Hughes Medical Institute
08.2022 - 02.2023
Software Support Tech
Pandemic Response Lab
11.2021 - 08.2022
Medical Laboratory Technologist
Pandemic Response Lab (PRL)
04.2021 - 11.2021
Clinical Laboratory Technician
Curative
10.2020 - 04.2021
Laboratory Technician
GeneDx
05.2020 - 10.2020
Research Assistant
George Mason University
04.2017 - 09.2018
B.S. - Biology, Computational Data Science
George Mason University
A.S. - Science
Northern Virginia Community College