Quality Assurance Data Manager (Cancer Center)

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Quality Assurance Data Manager (Cancer Center)

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 Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Quality Assurance Data Manager (Cancer Center)

Job Profile Title
Manager C

Job Description Summary
The Airways Research Program of the University of Pennsylvania seeks a full-time Data Manager to contribute to a broad portfolio of therapeutic and non-therapeutic studies. This position will (1) work in conjunction with Clinical Research Nurses and Coordinators (CRNs/CRCs) to ensure accurate and timely delivery of data compilation and submission, and (2) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements. This individual will work under general supervision

THIS POSITION IS CONTINGENT UPON FUNDING

Job Description

Specific responsibilities include (but are not limited to):

  • Attend and contribute to study-related meetings, including but not limited to Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits (e.g., OCR, DOCM, etc.) and ongoing training sessions.
  • Responsible for extracting data from source documents to complete Case Report Forms (CRFs) for complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, immunotherapies, etc.) Phase I, II, or III oncology clinical trials. This includes responding to data queries, coordinating independent central review of clinical trial end-points (e.g., imaging data), and coordinating Principal Investigator ("PI") sign-off.
  • Responsible for extracting data from source documents to complete CRFs or Non-CRF data collection tools for non-therapeutic studies (e.g., ancillary, biospecimen, correlative, retrospective, prospective, etc.). This includes coordinating the transfer of data from collaborating scientists, assisting biostatisticians with basic statistical analysis, and liaising with the Sponsor as needed to discuss issues and provide data management updates.
  • Participate in database set-up (including CRF and Non-CRF collection tools) for in-house protocols and Investigator-initiated clinical trials (IITs) including multi-site studies where Penn Medicine is the Lead Site. This includes preparing Data Management Plans (DMPs), data entry guidelines, data management reports, quality assurance planning, and other documents. Responsible for training project staff, ensuring all captured data follows the rules outlined by the protocol and data management plan, incorporating database updates as needed (e.g., protocol amendments), and participating in data cleaning activities including the generation and resolution of queries and discrepancies.
  • Champion all efforts related to maintaining complete, well-organized, and audit-ready study files from participant screening through final follow-up across trial portfolio. Ensure source documents are available for verification during routine monitoring and auditing visits.
  • Creating quality assurance/control measures to ensure clinical research required documentation is aligned with all institutional, FDA, GCP guidelines. As well as continuous surveillance to ensure process compliance is maintained.
  • Participate in research meetings (e.g., team, disease-site, etc.) and Sponsor/CRO teleconferences. Serve as an educational resource to Clinical Trials Nurses, Coordinators, and Research Assistants.
  • Provide coverage to meet departmental and organizational staffing needs (i.e. lunches, sick calls, vacations, or when a specific team member's workload exceeds capacity). May be asked, as time permits, to coordinate research scheduling (i.e., routine services and research-specific services) within clearly marked windows as directed by the study team; this includes coordination with the front desk, call center, and Penn Medicine satellite sites.
  • Maintain all relevant trainings and certifications (e.g., CITI, GCP, PENN CRC Certificate, Penn Profiler trainings, etc.).
  • Collaborate with the research nurse and coordinator to ensure all documentation for eligibility is in place. This includes, meeting all institutional and sponsor requirements.
  • Assist with start-up activities related to data collection, source document creation, and preparation for activation
  • Other responsibilities as reasonably assigned.


This position is contingent upon continued funding.

QUALIFICATIONS

Bachelor's degree and 5-7 years experience or an equivalent combination of experience and education required. 5 years experience in a life science area with data management experience desired with progressively more complex projects in a healthcare setting. Ability to handle multiple projects simultaneously. Must have strong interpersonal skills and communication skills (both spoken and written), and be ready to provide examples of each. Must be highly motivated, independent and a self-starter. Proficiency in basic Microsoft Office applications, e.g. Access, Word, Excel, PowerPoint. Experience with oncology is a plus.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$50,684.00 - $91,232.00

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/Perelman-Center-for-Adv-Medicine/Quality-Assurance-Data-Manager--Cancer-Center-_JR00044472-1

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