Research Project Manager (Department of Ophthalmology)
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.
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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
Research Project Manager (Department of Ophthalmology)
Job Profile Title
Manager Research Project A
Job Description Summary
The Project Manager will manage the day-to-day operations of data coordinating center for clinical research studies with various funding sponsors (government, industry, foundation). The responsibilities of the Project Manager will range from planning and developing guidance materials, data collection methods, and tracking systems for study operations to monitoring external site performance and study close-out procedures. The Project Manager will be responsible for ensuring regulatory compliance of all research projects. The Project Manager will lead the organizational planning for electronic data capture systems (EDCs) and oversee the data collection and data quality. The Project Manager will also support the Director of the Data Coordinating Center on the grant application, manuscript development and presentation of study findings. The ideal candidate for this position will have the ability to manage a dynamic pace and varied researchrelated responsibilities in accordance with University of Pennsylvania, GCP, FDA, and other governingentity guidelines.
Job Description
Job Responsibilities
Operations Management
Develop and maintain study documents including protocols, manuals of operations and procedures, data collection forms, training materials, and study/data presentation materials in various formats.
Lead or facilitate communications with various departments and external organizations, such as IDS, CRCU, collaborating academic medical centers, etc. as needed for study operations.
Lead the training and oversee implementation of study procedures of external study sites.
Oversee all research activities including recruiting, screening, enrolling and data collection and transmission for assigned research studies.
Support the director
and biostatisticians for the successful operation of the data coordinating center.
Regulatory Management
Implement regulatory plans f()r multi-site studies, effectively assigning team members as . needed for preparation of regulatory documentation.
Prepare and track all regulatory submissions for assigned studies including initial reviews, modifications, continuing reviews, deviations, and study close-outs.
Ensure regulatory compliance by all sites relying on Penn's IRB as the Central IRB and overseeing regulatory compliance by sites operating under their own institution's IRB, if applicable.
Prepare and submit all required documentation and reports for SAEs and protocol deviations per UPenn, sponsor, FDA and other applicable regulating entity requirements
Data Management
Lead the organizational planning for electronic data capture systems (EDCs) and track the build-out and maintenance of the EDCs for each assigned project ensuring data is collected and stored in accordance with HIPAA and University guidelines.
Oversee data entry, tracking data quality and completeness, and monitoring completion of study procedures at internal and external study sites.
Communicate with clinical sites for the data queries
Coordinate clinical site personnel for the data collection using data systems (e.g., Redcap)
Review interim and final data reports to identify and address missing data and data discrepancies.
Prepare and maintain data reports for progress reporting to investigators, funding sponsor, collaboration institutions, and community partners.
Additional Responsibilities
Coordinate and facilitate project meetings and data safety monitoring committee (DSMC) meetings including setting agendas, reserving conference rooms or sending virtual meeting information, preparation of meeting materials/notebooks.
Supervise trainees/students and study canvassers and manage workload and performance
Adhere to all University of Pennsylvania, GCP, and FDA guidelines.
Perform additional duties as need to ensure success of all research projects.
Qualifications
Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.
Position is contingent upon continued funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $71,528.00 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.
