Stacey Jorgenson
Raleigh,NC
Summary
Motivated Programmer with over 25 years of experience in the clinical research industry. Advanced knowledge of the clinical data management process and the clinical data lifecycle from start to finish. Works well in deadline-driven environments. Excellent communication skills. Detail oriented with the ability to work collaboratively in a cross-functional setting.
Overview
27
27
years of professional experience
Work History
Manager, FSP Principal Clinical Programmer
Catalyst Clinical Research, LLC.
06.2024 - Current
- Serve as the manager of all contract clinical programmers for both the clinical programming and biomarker clinical programming groups on my current FSP
- Responsible for end-to-end clinical programming activities and leadership/point of contact on multiple project teams across multiple therapeutic areas
- Establish productive working relationships across functional areas including safety, biostatistics, project management.
- Handling pre-processing and loading of non-CRF and CRF data across multiple platforms and multiple transfer file types.
- Create mapped datasets for multiple vendors across many therapeutic areas using standard processes in conjunction with mapping specifications created collaboratively with the data management team
- Ensure the efficiency, quality, and integrity of data reporting and project activities including validation of all programmed work through peer review and/or double programming
- Perform data checks as needed to ensure integrity and correctness of data displays and to understand structure and content of data using tools including many validated SAS macros, proc report, proc sql
- Develop/program adhoc edit checks, study specific edit checks for multiple clinical trials
- Creating metric reports, clean patient reports, etc to accurately reflect each stage of data cleanliness
- Develop/output patient profiles
- Create and/or review data specifications and other related study documents and plans including but not limited to data transfer specs, data validation specs, clinical data management plans, analysis dataset mapping specifications, etc.
- Receive/program data from multiple EDC platforms including RAVE, Medidata, OC, Veeva
- Create and/or validate data cut programs used to analyze clean data at certain timepoints throughout the life of the study
- Perform QC/validation of vendor datasets, clinical data listings, metrics and edit checks to verify the output
- Maintain detailed records of all activities related to each project, ensuring accurate documentation for future reference or audits.
- Contribute to ongoing improvement of programming processes and methodology
- Actively manage programming activities within parameters of project budgets
- Worked with team members to design and develop robust solutions to meet client requirements for functionality, scalability, and performance.
- Identified opportunities for process improvement, leading to a more efficient development cycle.
FSP Principal Clinical Programmer
Catalyst Clinical Research, LLC.
07.2013 - 06.2024
- Serve as clinical programming lead on multiple project teams
- Responsible for end-to-end clinical programming activities and leadership/point of contact on multiple project teams across multiple therapeutic areas
- Establish productive working relationships across functional areas including safety, biostatistics, project management.
- Handling pre-processing and loading of non-CRF and CRF data across multiple platforms and multiple transfer file types.
- Create mapped datasets for multiple vendors across many therapeutic areas using standard processes in conjunction with mapping specifications created collaboratively within the data management team
- Ensure the efficiency, quality, and integrity of data reporting and project activities including validation of all programmed work through peer review and/or double programming
- Perform data checks as needed to ensure integrity and correctness of data displays and to understand structure and content of data using tools including many validated SAS macros, proc report, proc sql
- Develop/program adhoc edit checks, study specific edit checks for multiple clinical trials
- Creating metric reports, clean patient reports, etc to accurately reflect each stage of data cleanliness
- Develop/output patient profiles
- Create and/or review data specifications and other related study documents and plans including but not limited to data transfer specs, data validation specs, clinical data management plans, analysis dataset mapping specifications, etc.
- Receive/program data from multiple EDC platforms including RAVE, Medidata, OC, Veeva
- Import Coding (Meddra, WHO Drug, etc.)
- Create and/or validate data cut programs used to analyze clean data at certain timepoints throughout the life of the study
- Perform QC/validation of vendor datasets, clinical data listings, metrics and edit checks to verify the output
- Maintain detailed records of all activities related to each project, ensuring accurate documentation for future reference or audits.
- Contribute to ongoing improvement of programming processes and methodology
- Actively manage programming activities within parameters of project budgets
- Worked with team members to design and develop robust solutions to meet client requirements for functionality, scalability, and performance.
- Identified opportunities for process improvement, leading to a more efficient development cycle.
Sr. Analyst, Clinical Data Programming
Quintiles, Inc.
01.2007 - 07.2013
- Providing clinical data management programming support for multiple studies across many therapeutic areas from start up to database lock.
- Create, develop and maintain clinical databases and data transfer files according to written specifications developed collaboratively within data management.
- Serve as a point of contact for all programming activities across multiple functions within the life of the study including but not limited to safety, biostatistics, coding, etc.
- Processing CRF data from a variety of platforms including, but not limited to, Medidata, Rave, Veeva and Oracle Clinical
- Converting data into SDTM analysis datasets for use by the biostatistics group
- Develop SAS listings/edit checks/reports for the cleaning/clinical review process using methods including SAS macros, proc report and proc sql. Working collaboratively with data managers on the creation of specs for edits checks/data listings, etc to facilitate data review.
- Handle the pre-processing and loading of non-CRF/vendor data from multiple platforms (.xls, .xlsx, .txt, .sas7bdat, etc.) and manipulate for transfer purposes for both internal and external customers
- Complete data transfers to both internal and external clients
- Import coding (Meddra, WHO Drug, etc.)
- Provide technical expertise and maintain good communication with both internal and external customers
- Review and provide input on data management related study documents and plans including, but not limited to, data transfer specs, data validation specs, analysis plans, analysis file programming specs, clinical data management plans, etc.
- Plan appropriately to ensure adherence to study timelines
- Provide support and input to continuous process improvements within clinical data management.
- Mentor other programmers and aid in their development.
Programmer/Analyst, Clinical Data Programming
Quintiles, Inc.
01.2000 - 01.2007
- Serve as lead programmer, communicating with internal/external team members across functional areas (data management, safety, coding, biostatistics)
- Data transfer programming – manipulate raw data to conform with specifications (client provided or otherwise created) both non-CRF and CRF data
- Programming of SAS checks, listings for data cleaning/review
- Import vendor data and manipulate for transfer
- Transfer data for both internal and external clients.
- Import coding (Meddra, WHO Drug)
- Provide technical expertise and maintain good communication with both internal and external customers
- Mentor other programmers and aid in their development.
Research Data Quality Control
Quintiles, Inc.
01.1998 - 01.2000
- Independently QC the output from the Biostatistics department: including, but not limited to the QC of analysis variables, analysis files, tables, listings and figures, reports for submission to FDA or safety meetings using both SAS programming and manual validation from source to output.
- Assist in the creation of submission packages to the FDA
- Maintained detailed records of all activities related to each project, ensuring accurate documentation for future reference or audits.
Education
Bachelor of Science - Applied Mathematics
North Carolina State University
Raleigh, NC05.1997
Bachelor of Arts - Economics
North Carolina State University
Raleigh, NC12.1997
Skills
- Demonstrated leadership with superior organizational and interpersonal skills
- Excellent time management
- Strong verbal and written communication with experience working in cross-functional settings
- Detail oriented with the ability to complex problem solve
- Understanding of GCP, CDISC and other industry standard practices regarding data management
- Experience with the clinical data lifecycle from database set-up and maintenance to database lock and archiving
- Strong SAS programming skills
- Knowledge and experience with multiple EDC systems including OC, Medidata, Veeva, etc
- Knowledge of Microsoft Office skills
- Experience with SDTM
- Ability to work collaboratively across functions within a project team
- Experience with multiple therapeutic areas including oncology, hematology, virology, respiratory, cardiovascular
Custom
26 total years of experience, Process CRF data from a variety of EDC platforms including but not limited to Medidata, RAVE and OC as well as import vendor data from multiple vendors, SAS listing/check/metric programming for clean/clinical review process using multiple SAS processes including SAS macros, proc report, proc sql, Provide technical expertise and maintain communication with internal/external customers, Knowledge of CDISC standards including SDTM, Oncology, Immunology, Virology, Cardiovascular, Hematology, Respiratory, Bachelor of Science, Applied Mathematics, North Carolina State University, 1997, Bachelor of Arts, Economics, North Carolina State University, 1997
Timeline
Manager, FSP Principal Clinical Programmer
Catalyst Clinical Research, LLC.
06.2024 - Current
FSP Principal Clinical Programmer
Catalyst Clinical Research, LLC.
07.2013 - 06.2024
Sr. Analyst, Clinical Data Programming
Quintiles, Inc.
01.2007 - 07.2013
Programmer/Analyst, Clinical Data Programming
Quintiles, Inc.
01.2000 - 01.2007
Research Data Quality Control
Quintiles, Inc.
01.1998 - 01.2000
Bachelor of Science - Applied Mathematics
North Carolina State University
Bachelor of Arts - Economics
North Carolina State University
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