Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Senior Clinical Database Developer

  • Jan 2023 - Present

  Tarrytown, New York, United States Maintain eCRF system for the duration of the study. Perform change control by defining any eCRF Change Requirement including CRF updates due to protocol amendments, clarifications, and post-production issues identified by users. Complete document change control requirements, version updates, UAT and migration testing. Control user access to database at study owner level. Assist with the creation of standard and custom reports in EDC using relevant report tools such as clinical reporting and… Show more Maintain eCRF system for the duration of the study. Perform change control by defining any eCRF Change Requirement including CRF updates due to protocol amendments, clarifications, and post-production issues identified by users. Complete document change control requirements, version updates, UAT and migration testing. Control user access to database at study owner level. Assist with the creation of standard and custom reports in EDC using relevant report tools such as clinical reporting and business object tools. - Act as a primary contact to data management team for assigned studies to provide all necessary technical support and to ensure quality programming and adherence to company standards. - Perform routine interface with cross-functional team members. - Act as liaison with CROs/vendors as needed, to establish and ensure company standards (for example, data transfer specifications) are implemented and maintained in all studies. - Assist Manager to: Support/develop and maintain SOPs related to EDC build process. - Assist Manager to: Participate and lead Clinical Database Development team meetings when needed. - Assist Manager to: Support Regeneron Secure Data Transfer system by managing access requests; user admin; user accounts and file structure. - Assist Manager to: Oversee the URL Core Configuration and iMedidata admin., while managing the needs of our CRO partners using the URL Core Configuration.

• Clinical Database Developer

  • Dec 2018 - Dec 2022

  Tarrytown, New York Work with Clinical Study Team through Study Data Manager to implement comprehensive eCRF system in Rave Architect using the Global CRF Library, reuse of prior studies, and new unique CRFs. Design unique CRFs in Rave Architect as needed per study team requirements. Define data validation requirements including edit checks, dynamics, derivations and custom functions. Program data validations in Rave Architect, including edit checks, dynamics derivations and custom functions prior to completion of… Show more Work with Clinical Study Team through Study Data Manager to implement comprehensive eCRF system in Rave Architect using the Global CRF Library, reuse of prior studies, and new unique CRFs. Design unique CRFs in Rave Architect as needed per study team requirements. Define data validation requirements including edit checks, dynamics, derivations and custom functions. Program data validations in Rave Architect, including edit checks, dynamics derivations and custom functions prior to completion of eCRF build. For complex and new custom functions, work with Medidata to oversee Medidata programming and testing of custom functions. • Facilitate UAT process - create UAT site and publish EDC system in UAT environment, invite Regeneron and CRO UAT participants via iMedidata. Resolve reported issues for the duration of UAT until system is deemed ready for go-live. • Set up Clinical Views per company standards, contribute to the creation of CDASH compliant eCRFs, maintain and contribute to company Standard Global Library. • When applicable, work with vendor on EDC and 3rd party system integration and perform external data loads as applicable, i.e., IxRS, labs, ECGs, etc. • When applicable, configure additional Medidata applications including but not limited to Coder and TSDV for use on study. • Ensure go-live of Rave EDC system in a timely manner prior to first subject first visit with full testing completed. Ensure proper documentation and approval of specifications and testing. • Maintain eCRF system for the duration of the study. Perform change control by defining any eCRF Change Requirement including CRF updates due to protocol amendments, clarifications, and post-production issues identified by users. Document change control requirements, version updates, UAT and migration testing. • Act as a primary contact to data management team for assigned studies to provide all necessary technical support and to ensure quality programming and adherence to company standards.



Memorial Sloan Kettering Cancer Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Application Analyst (Information Services)

  • 2017 - Nov 2018

  300 E 66th St New York, NY 10065 Gather necessary study requirements for multi-departmental research projects. Collect and record all of study team’s additional features requests, develop detail system and application specifications, including data conversion, interfaces, and custom reporting to ensure business requirements are met. Create a study into Medidata RAVE as per protocol guidelines and extra feature requests. Generate User Acceptance Testing (UAT) for study teams before approving studies to be published for patient… Show more Gather necessary study requirements for multi-departmental research projects. Collect and record all of study team’s additional features requests, develop detail system and application specifications, including data conversion, interfaces, and custom reporting to ensure business requirements are met. Create a study into Medidata RAVE as per protocol guidelines and extra feature requests. Generate User Acceptance Testing (UAT) for study teams before approving studies to be published for patient data entry. Ensure protocol is to team’s liking before publishing studies to production environment. Provide input and/or solutions for production related issues. Utilize standard templates to accurately and concisely write requirements and functional specifications. Participate in departmental special projects for study creation, data quality assurance, and audit preparation. ■ Responsible for working on multiple project tasks in support of study requirements, solution design, implementation and maintenance of eCRF solutions. ■ Develop and coordinate tests scripts, testing activities, test plan and business object reports for database quality validation and/or user acceptance testing to ensure accurate database structure and appropriate data collection. ■ Identify, understand and communicate configuration options within Rave EDC and Architect’s core system processes to end users to facilitate full system capability utilization. ■ Act as technical liaison with project team members and data managers to assist with the technical aspects of project delivery. ■ Coordinate and perform tests, including system, edit checks, custom functions, derivation, integration, and customer acceptance for modified and new systems and other post-implementation support. ■ Maintain SDLC (System Development Life Cycles) of each project. ■ Collaborate with business owners to develop and document scenario-based procedures to guide end users.

• Research Study Assistant II (Thoracic Oncology, Department of Medicine)

  • 2017 - 2017

  300 E 66th St New York, NY 10065 Complete necessary data collection requirements for inter-department research projects, databases, or protocols. Perform abstraction of data from source records in patient/human subject charts and from publications or data collection from outside physicians’ office. Collect and record all research data, and ensure completeness and accuracy of information. Enter data into the relevant data collection form as per established protocol and project timelines. Generate reports and perform advanced… Show more Complete necessary data collection requirements for inter-department research projects, databases, or protocols. Perform abstraction of data from source records in patient/human subject charts and from publications or data collection from outside physicians’ office. Collect and record all research data, and ensure completeness and accuracy of information. Enter data into the relevant data collection form as per established protocol and project timelines. Generate reports and perform advanced queries for principal investigator (PI), disease management team, sponsoring agency, Institutional Review Board/Privacy Board (IRB/PB), etc. Assist in literature searches to increase research efficiency. Ensure serious adverse events reports are completed and delivered to the sponsor. Participate in service and/or departmental special projects for data collection, data reporting, and quality assurance. ► Promoted to play a key role in creating and implementing 3 new research design tools to ensure data collection is performed within established timeframes. ► Increase data collection/query resolution efficiency ~50% by recommending changes or additions to established data fields. ► Perform advanced queries and independently audit work to ensure 100% accuracy.

• Research Study Assistant I (Thoracic Oncology, Department of Medicine)

  • 2015 - 2017

  300 E 66th St New York, NY 10065 Performed data collection, data entry and data analysis for research projects, databases, and research protocols. Compiled data and assisted in consolidating and analyzing data for presentation. Performed and responded to queries and assisted with statistical analyses. Updated manager with important research study information daily or as appropriate. Communicated with the PI when there were any issues or questions regarding participant eligibility, protocol timelines, etc., and met regularly… Show more Performed data collection, data entry and data analysis for research projects, databases, and research protocols. Compiled data and assisted in consolidating and analyzing data for presentation. Performed and responded to queries and assisted with statistical analyses. Updated manager with important research study information daily or as appropriate. Communicated with the PI when there were any issues or questions regarding participant eligibility, protocol timelines, etc., and met regularly with PI to review study progress. Performed self-audits to ensure protocol compliance. Ensured data compiled was clear, calculations accurate and data met all necessary data collection requirements. Notified manager and/or PI on protocol violations, deviations, etc., and ensured timely reporting to IRB/PB. Ensured Corrective Action Plans were distributed and implemented. ● Coordinated with research team to create 6+ protocol-specific tools. ● Collaborated closely with manager and/or PI in preparation of data and safety monitoring reports. ● Assisted with preparation for 3 internal and external audits or monitoring visits of a protocol and ● Represented the study upon site visits by external industry representatives and internal monitors.



Clinilabs

• United States
• Research Services
• 100 - 200 Employee

• Clinical Research Assistant

  • 2014 - 2015

  423 W 55th St, New York, NY 10019 Entered subject information into one or more databases with strict attention to detail. Read and understood protocols to enhance research efficiency. Managed and tracked project timelines and quality issues to ensure timely resolution. Provided data entry status reports in a timely manner. ■ Prepared for 50+ office/laboratory visits, ensuring efficiency and compliance with all regulations. ■ Assisted in 50+ subject visits, including direction contact with subjects, processing visit… Show more Entered subject information into one or more databases with strict attention to detail. Read and understood protocols to enhance research efficiency. Managed and tracked project timelines and quality issues to ensure timely resolution. Provided data entry status reports in a timely manner. ■ Prepared for 50+ office/laboratory visits, ensuring efficiency and compliance with all regulations. ■ Assisted in 50+ subject visits, including direction contact with subjects, processing visit data, ensuring completeness and integrity of source documents and case report forms, and other related duties. ■ Performed clinical assessments of 10+ study subjects per protocol under the direct supervision of a licensed clinician, including collecting vital signs, and performing electrocardiograms and venipunctures. ■ Maintained database information with 100% accuracy Additional Experience: Touro College, Brooklyn, NY: 2013 – 2014, Test Proctor Storage, Storage Plus, Long Island City, NY: 2006 – 2013, Customer Service Representative Show less