Clinical Research Database Programmer (Center for Cellular Immunotherapy)
- Employer
- University of Pennsylvania
- Location
- Pennsylvania, United States
- Salary
- Salary Not specified
- Date posted
- May 26, 2023
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Level
- Administrative
- Employment Type
- Full Time
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Clinical Research Database Programmer (Center for Cellular Immunotherapy)
University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Database Programmer (Center for Cellular Immunotherapy)
Job Profile Title
Data Analyst C
Job Description Summary
Under the leadership of Dr. Carl June, the Center for Cellular Immunotherapies (CCI) at the University of Pennsylvania is dedicated to accelerating and synergizing efforts that can quickly transition fundamental immunobiology research into the clinic. As a center for excellence in immunotherapies, the CCI drives scientific innovation in cellular and gene immunotherapies and has established the infrastructure necessary to accelerate the development of new treatments and the translation of this research into early phase clinical trials.
Job Description
The Clinical Research Database Programmer (DP) position works within the Center for Cellular Immunotherapies Clinical Operations Team. The primary mission of the Clinical Operations Team is to manage and optimize the clinical research infrastructure necessary for bringing these novel/personalized cell and gene therapies to patients. The key objectives of the Clinical Operations Team include:
- Supporting the translation of first-in-human investigational
cell and gene therapy products from the bench to
bedside.
- Managing/accelerating the clinical trial development and new
study activation pathways.
- Establishing internal and external collaborative
partnerships.
- Establishing/maintaining the infrastructure required to
standardize and optimize clinical trial development and execution;
and ensuring ongoing oversight/compliance.
- Developing/refining standardized processes, procedures, and
templates/tools to align with the changing regulatory landscape and
new scientific innovation.
- Ensuring the generation of high-quality, reliable and
statistically sound clinical data that can be used for reporting,
publication, endpoint analysis and further product
development.
- Identifying/implementing new technology/systems required to
enhance clinical research operations.
In this role, the Clinical Research Database Programmer will be responsible for performing study database development and programming functions in support of Phase 1, Penn-Sponsored clinical research studies as follows:
- Data Quality/Integrity/Security:
- Create/manage Vault CDMS system level database training
curriculum
- Perform Vault CDMS system level database training for both
Sponsor Team Members and Site end users; Perform
re-education/training as needed.
- Assist in the development/execution of core competency training
of new sponsor team members
- Investigate/resolve technical issues impacting study database
activity
- Provide technical guidance/support to the departmental Data
Management Team.
- Create/manage Vault CDMS system level database training
curriculum
- Data Extraction/Reporting:
- Support the development and maintenance of automated reporting
tools across EDC systems to expedite accurate, usable and
repeatable data outputs.
- Explore and implement alternative reporting
solutions
- Provide input into study and project level data analysis
plans
- Report generation/execution- including, but not limited to,
reports for routine monitoring visits, study management, regulatory
reporting, collaborator reporting, etc.
- Participate in the preparation, visualization, and presentation
of study data/reports for publication/presentation and/or
statistical analysis.
- Support the development and maintenance of automated reporting
tools across EDC systems to expedite accurate, usable and
repeatable data outputs.
- Study Database Design/Development/Maintenance:
- Assist in the development of technical documentation required
to support the CCI's utilization of Vault CDMS.
- Perform local validation/testing at the time of new Vault CDMS
System releases to evaluate the impact on CCI study
databases.
- Design and build study databases for CCI clinical trials
utilizing the Vault CDMS:
- Perform CRF design/development
- Build/configure the Casebook Schedule to align with study
requirements, maximize data collection/review activities, and
reduce inefficiencies.
- Configure/maintain required study-level system
functionality.
- Facilitate user acceptance testing (UAT)
- Manage database deployment activities
- Database amendments: Design/build database amendments,
facilitate validation and testing, and manage deployment
activities
- Perform CRF design/development
- Participate in the Vault CDMS CRF template development team;
Perform peer review/validation of new templates as
assigned.
- Assist in the development of standard rules and edit check
configurations within the Vault CDMS.
- Perform study level database peer review/validation as
assigned.
- Assist in the development of technical documentation required
to support the CCI's utilization of Vault CDMS.
- Process Development/Quality Improvement
- Work with team leadership to investigate specialized system
functionality and test innovative new ideas within the Vault CDMS;
provide recommendations for both CCI and SOM
use/implementation.
- Investigate Vault CDMS usage issues and malfunctions, identify
potential solutions, and make recommendations to Data Management
Leadership for appropriate corrective action and/or
implementation.
- Participate in meetings with Vault CDMS vendors to resolve
technical issues as required.
- Assist in developing/implementing local process
changes/improvements.
- Provide input on templates/tools, data standards,
etc.
- Assist in the development/maintenance of process documents,
workflows and template forms necessary to support CCI's use of the
Vault CDMS
- Work with team leadership to investigate specialized system
functionality and test innovative new ideas within the Vault CDMS;
provide recommendations for both CCI and SOM
use/implementation.
- Clinical Data Manager Responsibilities:
- Assist with clinical data management responsibilities as
assigned; including but not limited to:
- The development of study-specific data management
documentation; including Data Management Plans (DMP), Case Report
Form Completion Guidelines (CCGs), training materials,
etc.
- Data management review (DMR) of assigned studies to ensure data
quality/completeness.
- Execution/review/distribution of data management
reports.
- Investigator/Study Team training on the Clinical Database,
CRFs, and data entry requirements.
- Front-end support of other study-specific data management
responsibilities.
- The development of study-specific data management
documentation; including Data Management Plans (DMP), Case Report
Form Completion Guidelines (CCGs), training materials,
etc.
- Assist with clinical data management responsibilities as
assigned; including but not limited to:
Reference Information: The salary range included in the job posting encompasses the full range of employees at the University of Pennsylvania, with varying levels/years of experience, seniority, functional responsibilities, etc. Therefore it cannot be used as a precise indicator of the salary range for this position. The actual salary offered for this position will be determined by the Compensation Office in the Division of Human Resources and will be evaluated based on the qualifications of each individual candidate and internal equity.
Job Location: Hybrid Eligible- This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.
Qualifications
- Bachelor's Degree or equivalent experience; Degree in computer
science, data science, informatics or a comparable program
preferred.
- 2-3 years of related experience; or combination of equivalent
education/experience
- Qualified candidates should possess the following
skills:
- Experience working within an EDC and in CRF development/design;
or transferrable experience
- Basic experience using programming languages
- Working knowledge in one or more coding languages (JAVA, SQL,
Python)
- Ability to work and problem solve independently
- Demonstrated ability to manage multiple tasks simultaneously
and complete work within allocated time frames
- Excellent oral and written communication skills
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $73,581.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
- Health, Life, and Flexible Spending Accounts: Penn
offers comprehensive medical, prescription, behavioral health,
dental, vision, and life insurance benefits to protect you and your
family's health and welfare. You can also use flexible spending
accounts to pay for eligible health care and dependent care
expenses with pre-tax dollars.
- Tuition: Take advantage of Penn's exceptional tuition
benefits. You, your spouse, and your dependent children can get
tuition assistance here at Penn. Your dependent children are also
eligible for tuition assistance at other institutions.
- Retirement: Penn offers generous retirement plans to
help you save for your future. Penn's Basic, Matching, and
Supplemental retirement plans allow you to save for retirement on a
pre-tax or Roth basis. Choose from a wide variety of investment
options through TIAA and Vanguard.
- Time Away from Work: Penn provides you with a
substantial amount of time away from work during the course of the
year. This allows you to relax, take vacations, attend to personal
affairs, recover from illness or injury, spend time with
family—whatever your personal needs may be.
- Long-Term Care Insurance: In partnership with Genworth
Financial, Penn offers faculty and staff (and your eligible family
members) long-term care insurance to help you cover some of the
costs of long-term care services received at home, in the community
or in a nursing facility. If you apply when you're newly hired, you
won't have to provide proof of good health or be subject to
underwriting requirements. Eligible family members must always
provide proof of good health and are subject to
underwriting.
- Wellness and Work-life Resources: Penn is committed to
supporting our faculty and staff as they balance the competing
demands of work and personal life. That's why we offer a wide
variety of programs and resources to help you care for your health,
your family, and your work-life balance.
- Professional and Personal Development: Penn provides an
array of resources to help you advance yourself personally and
professionally.
- University Resources: As a member of the Penn community,
you have access to a wide range of University resources as well as
cultural and recreational activities. Take advantage of the
University's libraries and athletic facilities, or visit our
arboretum and art galleries. There's always something going on at
Penn, whether it's a new exhibit at the Penn Museum, the latest
music or theater presentation at the Annenberg Center, or the Penn
Relays at Franklin Field to name just a few examples. As a member
of the Penn community, you're right in the middle of the
excitement—and you and your family can enjoy many of these
activities for free.
- Discounts and Special Services: From arts and
entertainment to transportation and mortgages, you'll find great
deals for University faculty and staff. Not only do Penn arts and
cultural centers and museums offer free and discounted admission
and memberships to faculty and staff. You can also enjoy
substantial savings on other goods and services such as new cars
from Ford and General Motors, cellular phone service plans, movie
tickets, and admission to theme parks.
- Flexible Work Hours: Flexible work options offer
creative approaches for completing work while promoting balance
between work and personal commitments. These approaches involve use
of non-traditional work hours, locations, and/or job
structures.
- Penn Home Ownership Services: Penn offers a forgivable
loan for eligible employees interested in buying a home or
currently residing in West Philadelphia, which can be used for
closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible
employees on qualified expenses in connection with the legal
adoption of an eligible child, such as travel or court fees, for up
to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/Clinical-Research-Database-Programmer--Center-for-Cellular-Immunotherapy-_JR00072792-1
jeid-6b32f1791c0ce54b8d32f26c279bdda8
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