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Clinical Research Data Manager A (Center for Cellular Immunotherapy)

Employer
University of Pennsylvania
Location
Pennsylvania, United States
Salary
Salary Not specified
Date posted
May 22, 2024

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Position Type
Administrative, Academic Affairs, Research Administration
Employment Level
Executive
Employment Type
Full Time

Job Details



Clinical Research Data Manager A (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 Data Manager A (Center for Cellular Immunotherapy)

Job Profile Title
Clinical Research Data Manager A

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 Data Manager (CDM) 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 Data Manager (CDM) will be responsible for performing core data management functions for Phase 1, Penn-Sponsored clinical research studies as follows:
  • Data Quality/Integrity
    • Perform study level database training (End User and Sponsor Teams); Create/manage study database training curriculum; Perform re-education/training as needed.
    • Data Management Review- Develop Study Data Management Plans (DMP); Perform data cleaning and query management; Review raw datasets for trends/patterns, quality concerns/issues, gaps/omissions, etc; Monitor database “health status”/metrics- data entry status, monitoring source data verification and data cleaning performance, missing data, trends/patterns, etc. Work with the appropriate teams to manage data flow, address delays/issues, etc.
    • Manage primary end user support for the study database.
    • Investigate/resolve technical issues impacting use of the study database
  • Data Security
    • Manage database training documentation
    • Manage database access/permissions
    • Database lock and data archiving
  • Study Database Development
    • Evaluate new study core documents/amendments to determine data collection/reporting needs and regulatory requirements; Interface with key stakeholders to ensure completeness/accuracy
    • Create/manage database planning tools and database project timelines; Ensure the database development activities and post-production changes remain on track with anticipated deliverable timelines.
    • Create/manage CRF Completion Guidelines (CCGs) and data entry/reporting expectations.
    • Perform validation activities (relative to project requirements and applicable FDA regulatory guidelines)- Includes Metadata, Peer Review, UAT, etc.
    • Database Development:
      • Lead Study case report form (CRF) development and maintenance activities
      • Facilitate CRF review, validation and approvals.
      • Manage database deployment activities.
  • Data Extraction/Reporting
    • Provide input into study and project level data analysis plans.
    • Creating/maintaining reporting tools to support study needs.
    • 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.
  • Process Development/Quality Improvement
    • Assist in developing/implementing process changes and system improvements.
    • Provide input on templates/tools, data standards, etc.
    • SOP development and maintenance for business process needs


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.

This position is contingent upon funding.

Qualifications
  • Bachelor's degree required and 3-5 years of related experience.
  • Qualified candidates should possess the following skills:
    • Clinical research and clinical data management experience
    • Prior experience working within an electronic data capture (EDC) system
    • Experience in CRF development/design
    • Ability to work and problem solve independently
    • Excellent computer skills; including extensive proficiency in excel
    • Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
    • Excellent oral and written communication skills


Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$79,626.40 - $79,626.40 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-Data-Manager-A--Center-for-Cellular-Immunotherapy-_JR00087757-1



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