Project Manager A (Renal - Electrolyte and Hypertension)
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.
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Project Manager A (Renal - Electrolyte and Hypertension)Job Profile Title
Manager Research Project AJob Description Summary
Responsible for day to day management of complex projects conducted with collaborators both internal and external to Penn. With mentoring from the Principal Investigator, the Research Project Manager will take leadership role in developing study protocols, writing grants, managing the detailed operations of projects, analyzing qualitative and quantitative data, cultivating close relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journal. He/she will help develop the team's research strategy and will have ample opportunities to lead projects and co-author papers. Will be required to ensure that studies/research are conducted safely and according to protocol, provide supervision to educators and teams conducting the study/interventions and collaborates with peers from other Universities and funding agencies. Will also be responsible for coordinating grant applications and interacts with funding administrators and the University Business Office. Provides significant contributions to presentations and manuscripts, including multiple drafts for review and dissemination. Plays a primary role in other dissemination activities related to project findings.Job Description
Candidate will work closely with Physician leaders to provide high-level research project management services and oversee all aspects of the clinical research portfolio being performed for their research program. This includes highly complex hypertension/renal denervation studies, PKD, transplant, and other renal studies within the Renal, Electrolyte, and Hypertension Division. Studies may include any combination of: investigator-initiated, multi-center, industry sponsored, registry, or other patient oriented clinical and translational research projects.
He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, budget development and negotiation, interacting with funding administrators and the University Business office approval of both sponsored and internally-funded clinical research budgets to submitting for IRB closeout and archival of study files.
He/she will be working closely with the junior staff to mentor manage, train, review and initiate trials to ensure competitive activation and enrollment timelines. He/she is expected to troubleshoot operational issues on a daily basis, identify problems and develop solutions, and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, research billing, patient visits, transporting specimens, data entry, query resolution, monthly invoicing, and working with study monitors). They will enforce strong record keeping, ensure data integrity, collection/storage, tracking protocols, and supervise staff in regulatory affairs. Additionally, he/will be responsible hiring, training, and evaluating direct reports from junior staff.
Candidate will be expected to oversee all regulatory related work across ~30 studies, including but not limited to: submit local and central IRB submissions, maintain electronic and physical investigator site files, and maintain staff training qualification documents. He/she will be expected to communicate with sponsors, medical monitor, IRB, and other stakeholders regarding safety and deviation reporting; he/she will show vigilance in patient safety, protocol compliance, and data quality; and adhere to all University of Pennsylvania, IRB, and FDA guidelines. He/she may implement approved changes to procedures (CAPA) as needed and monitor results in addition to creating guidelines for standardizing internal procedures. Other duties include: AE/SAE reporting and escalation, research billing review in both EPIC, participate in sponsor/OCR/FDA monitoring and audits; submission to local and central IRB's (Advarra, WIRB, etc.), and submit RBN requests and PRA's to business office.
May require working off site and flexible hours. The Program Manager position will directly report to Director of Clinical Research.
A high level of independence, attention to detail, and strong communication skills are expected.
1) Project manage research studies conducted through the Renal Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines, including developing and driving study timelines, goals, and strategies, problem solving, and communicating with all key stakeholders (Investigators, sponsor, staff, etc).
2) Submit local and central IRB submissions for study initiation, study amendments, personnel changes, and study closure.
3) Create and maintain all documentation required by sponsor, CRO (eISF, physical regulatory binders), NIH or any funding sponsor.
4) Work with research sponsors, CROs, outside sites, and/or regulatory agencies on study initiation, monitoring, closeout visits, and any audits.
5) Assisting with study feasibility and selection, budget development and negotiation, study start-up activities, interacting with funding administrators and the University Business office approval of both sponsored and internally-funded clinical research budgets.
6) Hire, supervise, manage and train study teams and study staff, train staff in regulatory affairs and delegate regulatory work as needed, and on occasion serve as backup for study visits and related tasks on your projects.
7) Perform additional duties as assigned
Position is contingent upon funding.
Qualifications Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is requiredJob Location - City, State
Philadelphia, PennsylvaniaDepartment / School
Perelman School of MedicinePay Range
$51,824.00 - $78,096.00Affirmative 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/HUP/Project-Manager-A--Renal---Electrolyte-and-Hypertension-_JR00052011-1
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