Job Details

This ad is expired.

Project Manager A (Department of Pulmonary, Allergy and Critical Care)
Go to our website »

Position Number: 3685029
Location: Philadelphia, PA
Position Type: Health - Healthcare Administration

Project Manager A (Department of Pulmonary, Allergy and Critical Care)

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, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Project Manager A (Department of Pulmonary, Allergy and Critical Care)

Job Profile Title
Manager Research Project A

Job Description Summary
The Project Manager-A will be responsible for day-to-day management of 10-15 complex clinical research studies conducted within the Penn Interventional Pulmonary Research Team, consisting of protocols focused on new devices, diagnostic tests for lung cancer, and investigational drug for aPAP. This position will support Interventional Pulmonary Physician Investigators in clinical research ranging from observational trials to Phase I-IV investigational drug/product trials, including investigator-initiated and industry-sponsored trials. Under minimal supervision of the Principal Investigator (PI), the Project Manager A (PM-A) will carry out research activities including recruitment, consenting participants, management of study materials, ongoing monitoring of data, maintenance of staff certification at sites, adherence to procedures, IRB submissions, device and supply management, biospecimen handling (collection, processing, and shipping of hazardous goods), and preliminary data analysis with manuscript writing. This position will develop relationships with internal and external project partners; He/she will oversee all start-up activities including development of study documents (protocol, informed consent, CRFs), DOM CRS budget and CTA communication, preparation of meeting materials and presentations, as well as the design and maintenance of the study manuals of procedures. The PM-A will work on industry sponsored research across three sites (HUP, PPMC, PAH) that include working with central IRB regulation and frequent communication with study sponsors and CROs. He/She will coordinate site study teams, participate in study team meetings and ongoing protocol training/compliance meetings, and show vigilance in patient safety, protocol compliance and data quality. The PM-A will adhere to all University of Pennsylvania, FDA and GCP guidelines. Additionally, the PM-A will train and supervise a CRC-B position and 2 CRC-A positions that are currently supporting interventional pulmonary clinical trials. Responsibilities also include serving as a liaison between the PI and the rest of the team. A high level of independence, attention to detail, familiarity with IND/IDE/510 K study design and performance, and strong communication skills are expected.

Job Description

The Project Manager-A will be responsible for day-to-day management of 10-15 complex clinical research studies conducted within the Penn Interventional Pulmonary Research Team, consisting of protocols focused on new devices, diagnostic tests for lung cancer, and investigational drug for aPAP. This position will support Interventional Pulmonary Physician Investigators in clinical research ranging from observational trials to Phase I-IV investigational drug/product trials, including investigator-initiated and industry-sponsored trials. This position requires an on-site presence to support research staff, physician investigators, and study participants across Penn Campus. Responsibilities also include serving as a liaison between the PI and the rest of the team.

Duties include, but are not limited to:

Supervising/mentoring assigned clinical research staff and supporting personnel, meeting regularly with them to review/establish goals and evaluate workload
Developing/utilizing project management tools, delegating tasks, driving timelines, and working with research staff/supporting departments to ensure milestones are met over multiple projects/studies.
Correspondence and team meetings with study sponsors, CROs, and investigators.
Preparing/submitting regulatory packets, maintaining essential documents, staying on top of deadlines for continuing reviews, and prioritizing protocol amendments/modification. Participating in study feasibility, pre-site visits, site initiation visits, monitoring visits, audits, and close-out visits.
Reviewing/revising/presenting program processes, SOPs, and guidance documents to ensures staff are properly trained on and utilizing the most recently approved processes
Leading study start-up, team meetings, and ongoing protocol trainings
Participating in study feasibility, pre-site visits, site initiation visits, monitoring visits, audits, and close-out visits
Assisting in the development/maintenance of study specific case report forms, source document tools, trackers, and templates to be used by research staff
Data collection, data entry, eCRF completion
Subject screening, scheduling, and enrollment/study visit completion
Conducting QA/QC reviews of participant charts and regulatory files to ensuring adherence to protocol, GCP guidelines, and SOPs
Work with IDS on investigational drug trials, oversee device management, and oversee biospecimen handling (eg. collection, processing, and shipping of hazardous materials)
Showing vigilance in patient safety, protocol compliance, and data integrity
Adhering to all University of Pennsylvania, FDA, and GCP guidelines

A high level of independence, attention to detail, familiarity with IND/IDE/510 K study design and performance, and strong communication skills are expected.

In addition to above, the PM-A has Research Coordinator duties (including screening, recruitment, consenting, conducting study visits, eligibility review, processing/shipping samples per protocol) as needed to meet the needs of the Investigational Pulmonary Clinical Research team. The PM-A would report directly to the Principal Investigators and remain in frequent communication with all other physician investigators.

QUALIFICATIONS: (Qualifications should clearly indicate those that are required and those that are preferred.)

Proactive problem solving abilities; effective communication and writing skills; robust organizational and time management skills; flexible and able to multi-task; strong attention to detail; demonstrated ability to not only lead, but also work as part of a team; capacity to motivate and influence timelines; knowledge of IRB, human research protection regulations, and good clinical practices; exceptional work ethic and appreciation for diversity required. Position contingent on funding.

Project Manager A: Bachelor's degree required and 3-5 years of related experience or an equivalent combination of education and experience required. Master's degree preferred. Regulatory and clinical trial coordination experience preferred.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$51,824.00 - $78,096.00
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/Perelman-Center-for-Adv-Medicine/Project-Manager-A--Department-of-Pulmonary--Allergy-and-Critical-Care-_JR00064536-2