• Lead Clinical Data Management process for clinical studies from study startup through database lock, ensuring collection, review, reprocessing, and submission of data in support of achieving regulatory approval of in vitro diagnostics (IVD) and companion diagnostic (CDx) assays domestically and internationally

• Draft and finalize key study deliverables such as Data Management Plan, Data Review Plan, Data Dictionary, and Data Transfer Agreements as well as non-study documents such as templates, SOPs, and Work Instructions

• Design and validate Electronic Data Capture (EDC) database, Electronic Case Report Forms (eCRFs), and eCRF Completion Guidelines (eCCGs) within Veeva EDC

• Manage storage and maintenance of Data Management documents in Veeva eTMF, including version control and compliance with regulatory requirements

• Lead procurement, configuration and delivery of hardware for data storage to sites

• Lead data transfer, backup and archival process for all clinical studies

• Developed cloud-based pipeline via AWS for immediate site-to-database delivery of data, allowing for rapid review of data and significantly reducing timelines compared to traditional hardware-based transfers.

• Automated process for downloading and tracking of data from sites as it is received, streamlining operations for all of Clinical Affairs

• Developed Python and R programs for review, modification and transfer of data, increasing quality of data and reducing timelines

• Coordinate database development from study start up to closeout with Biometrics, cross-functional, and vendor team members
• Participate in a wide range of database design, programming, validation and testing activities for EDCs such as Medidata Rave, Medrio and OpenClinica
• Develop and maintain interactive data visualizations and dashboards for the purpose of data review and identification of emerging trends or insights
• Identify opportunities to improve process efficiencies through automation and drive/oversee the implementation of these processes
• Review and assist in creating departmental SOPs, guidance documents and work instructions (WIs)
• Work in tandem with the Biometrics team to develop a standardization of design, documentation, testing, and implementation of clinical data collection (i.e., CRF standards), and clinical database review
• Vendor oversight and full awareness of data workflows to and from the Biometrics teams

• Design and implement data collection and reporting tools to support cleaning and analysis of clinical trial data
• Create interactive visualizations and dashboards that allow for data review, analysis and risk-based monitoring
• Perform all aspects of the data cleaning process including but not limited to data listing reviews, SAE reconciliation and third-party vendor data reconciliation, with a high degree of accuracy and in accordance with Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs)
• Database testing and development, vendor/data management, and creation and maintenance of internal documents such as Data Management Plans, eCRF Completion Guidelines, and Manual Review Listing Plan
• Manage the process of data extracts and imports from multiple sources to build an integrated database for all clinical data
• Develop functional specifications, system and report design specifications, and supports validation requirements as needed

• Extract, clean and aggregate data (Hadoop/Hive and Greenplum). Create project specific schemas, tables, functions, views to process and store data. Ensure quality and integrity of data and procedures.
• Leverage database using SQL (Postgres) to lead data extraction projects for clients and fulfill data requests from all departments
• Create analytical business reports combining digital data and survey research results to provide accurate, granular insights to clients' digital marketing strategies
• Provide analysis and insight on research process regarding setup, logic, feasibility, performance, potential issues, and data output
• Ensure quality and integrity of data with creation of complex syntax in SPSS and Excel