Pancreatic Cancer Clinical Data Manager (Hybrid Eligible) (Cancer Center)

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Pancreatic Cancer Clinical Data Manager (Hybrid Eligible) (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
Pancreatic Cancer Clinical Data Manager (Hybrid Eligible) (Cancer Center)

Job Profile Title
Manager B

Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC.

Job Description

The ACC CRU Pancreas Research Team seeks a full-time Clinical Data Manager (CDM) to organize, coordinate and implement complex cancer studies involving a wide variety of investigational products and various sponsors. This position will report directly to the Pancreas Research Program Manager and work directly with Physician Investigators ("PI") on clinical research performed. He/she will be responsible for all aspects of clinical data management and clinical trial coordination. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.

The CDM is an integral and essential member of the ACC CRU Pancreas Research Team. We are looking for an enthusiastic, professional and committed team member to work closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National Cancer Institute (NCI) and is considered one of the top 10 cancer centers in the country. We are looking for a CRC that will help accelerate this momentum through the conduct of cutting edge clinical trials.

Career Development Opportunities

The ACC is focused on career development of CDMs, and offers an advanced infrastructure of leadership and training to guide and support new CDMs from initial training, to continued professional growth.

Position Responsibilities:

Clinical Data Manager B Responsibilities

This individual will work under general supervision

The Clinical Data Manager (CDM) will be responsible for the coordination and data management of complex oncology clinical research protocols, including accurate data collection and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CDM is responsible for data quality and documentation for assigned clinical trials conducted by the ACC CRU Pancreas Research Team to ensure that the clinical data collection is accurate and all protocol requirements are captured. The CDM will demonstrate vigilance in protocol compliance, and data quality, and will participate in data organization for research publications, with potential for co-authorship. Additional details of these responsibilities are provided below:
  • Coordinate the conduct of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials and registries within the ACC CRU Pancreas Research Team .
  • Assist the Program Manager in the development and review of study-specific data management documents, as well as sponsor data management standard operating procedures. Under the guidance of the Program Manager, prepare protocol amendments and changes to clinical documents.
  • Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements. Produce and provide metrics on data entry/processing to the Project Manager.
  • Oversee clinical data entry by the Pancreas Team coordinators and ensure timely submission of clinical documents and patient status updates in the electronic data capture systems. Monitor staffing schedules. Assist in implementing process changes and system improvements.
  • Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the ACC CRU Pancreas Research Team Program Manager.
  • Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in protocol compliance and data quality.
  • Participate in the development/maintenance of electronic study specific case report forms (i.e. REDCap, CTMS etc.) and source document tools. Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts.
  • Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms typically within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.
  • Work in conjunction with team Program Manager, PI, Research Nurse, regulatory coordinator to document and report adverse events and deviations; participate in any inspection (e.g. internal and external audits) that takes place with the trials, as required. Assist in obtaining the appropriate signatures for regulatory forms.
  • On behalf of the site, participate in weekly or bi-weekly Sponsor teleconferences to review the status of ongoing patients and slot assignments/allocations for next dose levels; share study-wide updates/issues with the Research Team's Program Manager and study team members who were not able to participate. Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Provide regular study and enrollment updates to the research team. Work as a part of the research team to maximize the efficiency and quality of research performed, including developing work instructions.


May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues.

Bachelor's degree and 3 to 5 years of experience or equivalent combination of education and experience required.

THIS POSITION IS CONTINGENT UPON FUNDING

Job Location - City, State
Philadelphia, Pennsylvania
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week that is divided between working onsite and working remotely

Department / School
Perelman School of Medicine

Pay Range
$43,919.00 - $66,183.00

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/Pancreatic-Cancer-Clinical-Data-Manager--Hybrid-Eligible---Cancer-Center-_JR00053992-1

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