Experience

Ethyca

• United States
• Software Development
• 1 - 100 Employee

• Staff Software Engineer

  • May 2022 - Present



Argenta

• Russian Federation
• Information Technology & Services
• 1 - 100 Employee

• Manager of Programming and Data

  • Sep 2019 - Apr 2022

  • Create custom programs to generate reports to respond to study team and external information requests.• Develop and program study specific validation checks and necessary reports.• Create custom applications to support business and study needs.• Preform code reviews.• Write unit and/or integration tests to ensure code quality.• Create automated testing solutions for web-based system.• Create and manage CI/CD pipelines.• Deliver quality services, innovative technical solutions, and create an innovative culture.• Provide expert advice on clinical project management for Argenta Global and customers, support development of business proposals for new projects and may support project management tasks for clinical trials. • Direct, consult, and provide advice on Data Management for Study Teams by providing expert data collection advice and clinical trial database design. Provide consultation to customers for Data Management needs, Data exports, README files, and data cleansing checks.• Build an exclusive Argenta Global library of eCRFs for use with our studies. Design, create, and maintain databases for the storage and management of clinical data.• Create SOPs to support all Data Management tasks/services.• Contribute to the preparation of the data management section of protocols and execute them. Manage the design, creation, and implementation of electronic data collection tools to collect necessary data for clinical studies.• Contribute to software vendor identification and selection to enhance or fix gaps in links between systems to ensure data management will work effectively.• Identify and resolve (or initiate the resolution of) bugs in conjunction with the Study Monitor, Project Manager, or directly with the Investigational site to ensure high quality and consistent data, resulting in timely database locks.• Manage data locks as appropriate in a timely manner for statistical review, blinded interim quality review, and interim and final database lock.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Programmer, Data Management Group

  • Mar 2016 - Sep 2019

  • Develop programming methods as needed including processing of clinical data required for analysis of clinical trials for all phases and train programmers on current methods.• Provide expert quality Programming expertise to other collaborating departments.• Provide successful and high quality programming expertise on all clinical studies• Oversee all Programming tasks related to clinical studies including but not limited to the following:• Processing of clinical data required for analysis of clinical trials for all phases• Create clinical trial databases• Develop SAS coding and table templates for preparing, processing and analyzing clinical data• Provide high level, accurate programming• Generate QC summary tables, data listing and graphs for analysis of study data using SAS standard coding practices as needed• Provide/acquire tools to improve programming efficiency or quality Validation work of other programmers/analyst• Create/review Programming/Validation Plan, specification for data sets• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues support data queries from other groups (Biostatics, Clinical Development, Clinical Operations, Regulatory and/or Marketing)

• Senior Programmer, Data Management Group

  • Sep 2014 - Mar 2016

  • Develop programming methods as needed including processing of clinical data required for analysis of clinical trials for all phases and train programmers on current methods.• Provide expert quality Programming expertise to other collaborating departments.• Provide successful and high quality programming expertise on all clinical studies• Oversee all Programming tasks related to clinical studies including but not limited to the following:• Processing of clinical data required for analysis of clinical trials for all phases• Create clinical trial databases• Develop SAS coding and table templates for preparing, processing and analyzing clinical data• Provide high level, accurate programming• Generate QC summary tables, data listing and graphs for analysis of study data using SAS standard coding practices as needed• Provide/acquire tools to improve programming efficiency or quality Validation work of other programmers/analyst• Create/review Programming/Validation Plan, specification for data sets• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues support data queries from other groups (Biostatics, Clinical Development, Clinical Operations, Regulatory and/or Marketing)



Novartis Animal Health

• China

• Principal Data Manager

  • Mar 2011 - Sep 2014

  • Manage the activities of the Data Management function in the collection and management of clinical trial data to ensure timely, efficient, and high quality Data Management deliverables.• Lead the creation and development of global programs to establish and maintain a suitable Data Management system for R&D.• Lead the development of global databases including schema design, programming, and end user reporting.• Lead and/or function as a member of the Global Data Management team by providing input to and undertaking the implementation and maintenance of global working practices and standards.• Assist Statisticians with SAS programming.• Manage Business Administration duties within the Global Data Management System including direct coordination with IT, Quality, and other system stakeholders.• Mentor and train Clinical Data Managers.• Manage relationships with Novartis Pharma Data Management to maximize the advantages of sharing best practices, system sharing, and training opportunities.• Coordinate and advise on clinical data management activities within R&D and between other Novartis Animal Health departments by establishing processes for on-going communication of business needs and strategy.• Participate in R&D teams by providing expert advice in data collection techniques.• Lead the technical liaison to regulatory agencies for global data management systems and processes.• Interact/collaborate with other functions to ensure transfer of knowledge and deliverables.• Work according to and ensure the compliance with external and internal guidelines (e.g. SOP's and GxP's).

• Clinical Data Manager II

  • Sep 2003 - Feb 2011

  • Participate in the activities of the Data Management function of collecting and managing of clinical trial data to ensure timely, efficient, and high quality Data Management deliverables.• Lead the creation and development of global programs to establish and maintain a suitable Data Management system for R&D.• Lead the development of global databases including schema design, programming, and end user reporting.• Function as a member of the Global Data Management team by providing input to and undertaking the implementation and maintenance of global working practices and standards.• Manage Business Administration duties within the Global Data Management System including direct coordination with IT, Quality, and other system stakeholders.• Mentor and train Clinical Data Managers.• Manage relationships with Novartis Pharma Data Management to maximize the advantages of sharing best practices, system sharing, and training opportunities.• Coordinate and advise on clinical data management activities within R&D and between other Novartis Animal Health departments by establishing processes for on-going communication of business needs and strategy.• Participate in R&D teams by providing expert advice in data collection techniques.• Lead the technical liaison to regulatory agencies for global data management systems and processes.• Interact/collaborate with other functions to ensure transfer of knowledge and deliverables.• Work according to and ensure the compliance with external and internal guidelines (e.g. SOP's and GxP's).

• Data and Document Specialist

  • Feb 2001 - Sep 2003

  • Participate in the activities of the Data Management function of collecting and managing of clinical trial data to ensure timely, efficient, and high quality Data Management deliverables.• Assist in the creation and development of global programs to establish and maintain a suitable Data Management system for R&D.• Function as a member of the Global Data Management team by providing input to and undertaking the implementation and maintenance of global working practices and standards.• Manage Business Administration duties within the Global Data Management System including direct coordination with IT, Quality, and other system stakeholders.• Coordinate and advise on clinical data management activities within R&D and between other Novartis Animal Health departments by establishing processes for on-going communication of business needs and strategy.• Participate in R&D teams by providing expert advice in data collection techniques.• Participate in the technical liaison to regulatory agencies for global data management systems and processes.• Interact/collaborate with other functions to ensure transfer of knowledge and deliverables.• Work according to and ensure the compliance with external and internal guidelines (e.g. SOP's and GxP's).