bernice simon

currently a data manager, biospecimen operations!

education

  • university of maryland, baltimore county (ongoing)
  • b.s. chemistry
  • montgomery college
  • a.s. chemistry and biochemistry

skills/tools

  • clinical data management/knowledge
  • git, gitlab, github
  • data processing & pipelines
  • linux/ubuntu proficiency
  • python programming
  • R programming
  • technical writing/knowledge
  • highly organized
  • time management
  • clinical research
  • technology research
  • data entry
  • data analytics
  • html5/css
  • microsoft office
  • excel
  • outlook
  • word
  • powerpoint
  • libreoffice
  • teams
  • zoom
  • slack
  • teamwork/team collab
  • computer skills
  • 100-111 WPM typing speed
  • Jira
  • leadership
  • efficiency
  • streamline
  • automation
  • federal contract forecasting
  • federal contract budgeting
  • financial analysis
  • strong attention to detail
  • dependable

professional summary

Results-driven and highly skilled Data Manager, Biospecimen Solutions with over two years of clinical data management experience in the pharmaceutical and biotechnology industries. Adept at managing complex clinical trials, leading cross-functional teams, and delivering clean, analyzable data for clinical studies. Strong background in data processing systems, data pipeline engineering, automation, technical troubleshooting, and client relationship management. Known for collaborating effectively across technical and clinical teams, creating innovative tools, and delivering high-quality data solutions that improve speed, accuracy, and scalability.

experience

data manager, biopspecimen solutions, quartzbio - buckeystown, MD (remote)

feb 2023 - present

  • Lead data management activities for complex clinical trials across portfolios including Takeda, Blueprint, and GSK, ensuring data integrity, accuracy, and regulatory compliance.
  • Manage project timelines, deliverables, and internal/external team communications, in-cluding coordination for UAT, DB lock, and CRF reconciliation.
  • Run local vSIM pipelines in Linux environments to create and troubleshoot internal JSON configuration files, validate data outputs, and ensure proper syncing of biomarker da-tasets across multiple studies.
  • Troubleshoot configuration-related pipeline errors using system logs, custom-built scripts, and exploratory analysis, applying version control via GitLab to manage and re-solve issues efficiently.
  • Piloted the Data Mapper PoC with SolveBio API to transform vSIM data using EDP tem-plates, collaborating closely with engineering and data product teams.
  • Provided technical evaluations and hands-on feedback on AI tools like Zipstack/Unstract to assess integration feasibility for expected samples scheduling.
  • Served as the primary technical mentor and ambassador for new team members, conduct-ing regular onboarding sessions, technical walkthroughs, and training in custom work-flows and Linux-based toolsets.
  • Developed custom R functions to enhance the flexibility and scalability of data checks across portfolios, including complex flagging systems for consent date discrepancies, duplicate detection, and assay result interpretation.

key achievements:

  • Built robust local pipelines using Linux to process and transform large biomarker da-tasets, vendor inventory manifests, and assay results, drastically reducing run times and minimizing downstream QC issues.
  • Created a Python utility to split a massive, system-crashing CSV file locally, enabling timely validation and report generation despite client-side delays.
  • Authored a portfolio-wide R-based custom check to automatically flag pipeline-breaking errors, adopted across multiple studies to improve QC.
  • Achieved a 4.0 "Above Standards" rating for technical excellence and collaboration across departments and product teams.
  • Received client accolades for timely, proactive support and high-quality deliverables, in-cluding recognition from Turnstone and internal leadership.

relevant data management skills:

  • Clinical Data Management: Database lock processes, CRF design and review, audit sup-port, query review, reconciliation workflows.
  • Data Processing & Pipelines: Custom script creation for local and cloud-based pipelines; experience managing JSON-based configuration files for biomarker data platforms.
  • Linux/Ubuntu Proficiency: Comfortable navigating terminal environments; executing shell scripts; managing CRON jobs for data automation; using local virtual environments to test and validate pipeline changes.
  • Programming & Automation: Python (data utilities, file handling), R (custom checks, QC reports), Power Automate (email parsing, notification workflows).
  • Collaboration & Leadership: Cross-functional team leadership, mentoring, client rela-tionship management, technical documentation.
  • Quality Assurance & Testing: Debugging pipeline runs, UAT coordination, code review, validation of CRF and eCRF systems.

relevant technical tools & profeciencies:

  • EDC Systems: RAVE, Veeva, IBM
  • Programming & Scripting: Python, R, Bash, Power Automate
  • Data Management Tools: GitLab, JSON configs, internal pipeline frameworks
  • Office & Productivity: Microsoft Excel, Word, Outlook, LibreOffice
  • Documentation & Tracking: Confluence, Jira, Asana, SmartSheets
  • Operating Systems: Linux (Ubuntu), macOS, Windows
  • Data Pipeline Environments: Custom CLI utilities, CRON jobs, shell scripting, log pars-ing, local validation/testing tools


previous experience

lead administrative services coordinator and operations technician, Thermo Fisher Scientific - NCI-CAR/DMID

jun 2022 - nov 2022

  • Utilizes Agile methods and user experience research to streamline efficiency and productivity projects such as new SOPs for weighing, QC checking, and shipping of chemical shipments leading to a 30% cut in technician time under the hood
  • Writes Power Automate automations to increase productivity for scanning in thousands of biospecimens a day and email extractions of shipping lists, cutting time by 20%
  • Manages federal contract budgeting, reorganization, implementation, and integration of new budgeting management system under Microsoft Dynamics Navision as well as procurement activities
  • Participates in forecasting and forecasting meetings to determine prioritized purchases for the upcoming months and contract year
  • Inputs orders, making sure to target women owned, veteran owned, or small business owned companies
  • Receives invoices and quotes for procurements for lab needs
  • Designs and formulates PTO and On-Call Excel tracker on Microsoft Teams for ease of labor tracking issues with federal budget tracker
  • Works closely with managers to support discrepancies, inventory maintenance and database updates
  • Uses an inventory management system (inTrak and Global Trace) for data entry, sample tracking, and management of samples
  • Assures compliance to cGMP company quality systems and follows SOPs, facility safety guidelines, and Food & Drug Administration (FDA) requirements
  • Prepares samples, clinical agents, and biospecimens for pickups, courier deliveries, and shipments in BSL-2 laboratory
  • Performs internal specimen consolidation and modernization projects under the mentorship of a Lead Operations Technician
  • Receives and handles inventories of specimens of human, animal, and/or plant origin at temperatures ranging from ambient to -196°C and having potentially hazardous properties

labroatory scientist - chemistry, Thermo Fisher Scientific - WRAIR

sep 2019 - jun 2022

  • Wrote and maintained advanced Excel formulations for the processing and organization of over 1 million chemical compound containers saving hundreds of hours in manual checks
  • Wrote and created templates for chemical warning labels for hundreds hazardous compounds
  • Trained new or temporary employees in computer and laboratory operations
  • Assisted in writing SOP’s pertaining to laboratory and computer procedures
  • Quickly and efficiently processed, received, and sent out chemical orders and shipments from WRAIR to support multiple government divisions and facilities
  • Adhered to excellent knowledgeability of good laboratory practice and safety
  • Assisted in the validation and maintenance of chemical structures in the chemistry database and other data in the Core laboratory Information Management System (CoreLIMS) including making changes and updating the chemistry database as appropriate
  • Processed orders through the CoreLIMS plus hand issue and hand inventory requests observing all OSHA, GLP, and GMP regulations as appropriate
  • Properly stored, handled, and disposed compounds in accordance with OSHA and EPA or MDE regulations taking into consideration compound stability, hazards, and potential chemical interactions

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