Clinical Research Project Manager B/C at University of… · Presbyter…

Clinical Research Project Manager B/C

Location: Presbyterian Medical 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 Large Employers in 2023.

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.

Posted Job Title

Clinical Research Project Manager B/C

Job Profile Title

Clinical Research Project Manager B

Job Description Summary

Clinical Research Project Manager B
The Project Manager B will provide advanced project management and operational expertise in support of clinical research studies conducted within the Cardiovascular Division of PPMC. PM B position provides independent oversight of study operations, including project planning, team management, and study execution.

The Project Manager B will serve as the primary project manager for assigned studies, with accountability for study execution, operational planning, and overall performance including enrollment. This role will coordinate complex study activities across multidisciplinary teams including investigators, coordinators, core labs, and external collaborators. The Project Manager B will ensure studies are conducted in accordance with protocol requirements, sponsor expectations, and all applicable regulatory and institutional guidelines.

Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Performs screening visits, consenting of participants, entering data into databases. Coordinate several investigational trials within the cardiovascular division of PPMC, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements

Responsibilities include developing and maintaining detailed project plans and timelines, overseeing recruitment and enrollment strategies, and ensuring adherence to study milestones. PM B will lead track progress and proactively identify and resolve operational challenges. This individual will oversee compliance reviews and will ensure audit and inspection readiness across assigned studies. PM B will supervise and mentor research staff, and will provide guidance on day-to-day study operations, workload prioritization, and performance expectations. This role will promote consistency in processes, tools, and documentation, and contribute to the development and implementation of best practices and standard operating procedures. In collaboration with PPMC Administrative Director, the Project Manager B will obtain detailed knowledge of all components of trial protocols screening and enrolling patients, conducting follow-up activities, abstracting medical and demographics data from medical records, completing source documents and case report forms, data entry using various electronic data collection systems, managing the adverse event reporting process.
The Project Manager B functions with a high degree of independence in managing assigned projects but escalates strategic decisions and high-level study direction to senior leadership (e.g., Administrative Director, etc.).


Clinical Research Project Manager C
The Project Manager C will support the PPMC Cardiovascular Research and be responsible for day-to-day operations of multiple clinical research projects. The Research Project Manager will take leadership role in developing study documents managing the detailed operations of projects, coordinating activities in multiple studies, quality control and will lead project strategy. PM C will be required to ensure that studies/research are conducted safely and according to protocol, provide supervision to the teams conducting the study/interventions and collaborates with the funding agencies..

The Project Manager C will serve as the primary project manager for assigned studies, with accountability for study execution, operational planning, and overall performance including enrollment. This role will coordinate complex study activities across multidisciplinary teams including investigators, coordinators, core labs, and external collaborators.

This is a leadership position and will involve hiring, onboarding and oversee the detailed operations of clinical research activities including recruitment, conducting research visits, data entry. Coordinate investigational trials within the cardiovascular division of PPMC, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements

PM C will lead track progress and proactively identify and resolve operational challenges. This individual will oversee compliance reviews and will ensure audit and inspection readiness across assigned studies. PM C will supervise and mentor research staff, and will provide guidance on day-to-day study operations, workload prioritization, and performance expectations. This role will promote consistency in processes, tools, and documentation, and contribute to the development and implementation of best practices and standard operating procedures.

The Project Manager C functions with a high degree of independence in managing assigned projects but escalates strategic decisions and high-level study direction to senior leadership (e.g., Administrative Director, etc.).

Job Description

This position is contingent upon favorable funding.

Clinical Research Project Manager B

Job Responsibilities

• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with Good Clinical Practice (GCP) and all applicable regulatory requirements.
• Supervise, manage, and mentor study teams including onboarding, training, workload management, and performance oversight; develop and drive study timelines, recruitment strategies, and operational plans.
• Assist in research studies using approved protocols, according to GCP. Familiarize with all components of study protocols by review of study. Attend Investigators Meetings. Assure accurate, completion and updates of the Delegation of Duties and Authorized Signatures Form. Confer with the pharmacist as needed to assure the availability of study drug. Create, maintain research data, regulatory files.
• Timely initiation of screening, enrolling patients. Screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists. Recruit patients, explain protocol, consent forms. Assure original signed consents are maintained in the study binder. Complete screening/enrollment logs and submit to sponsor, as protocol.
• Complete all source documents and worksheets. Complete and/or enter all clinical record forms (CRFs). Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Recruiting, training, and supervising full time research staff.
• Develop/ Help create EPIC Smart phrases.

Qualifications

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.

Clinical Research Project Manager C

Job Responsibilities

• Staff supervision: Assist and train direct and/or indirect research staff on procedures as required per protocol(s). Includes onboarding and training, data and lab management, protocol compliance and QC/QA, human subjects protection and GCP, and project assignments/staff mentoring/biannual performance appraisal completion.
• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with Good Clinical Practice (GCP) and all applicable regulatory.
• Assist in research studies using approved protocols, according to GCP. Familiarize with all components of study protocols by review of study. Attend Investigators Meetings. Assure accurate, completion and updates of the Delegation of Duties and Authorized Signatures Form. Confer with the pharmacist as needed to assure the availability of study drug. Create, maintain research data, regulatory files.
• Timely initiation of screening, enrolling patients. Screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists. Recruit patients, explain protocol, consent forms. Assure original signed consents are maintained in the study binder. Complete screening/enrollment logs and submit to sponsor, as protocol.
• Complete all source documents and worksheets. Complete and/or enter all clinical record forms (CRFs). Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Recruiting, training, and supervising full time research staff.
• Develop/ Help create EPIC Smart phrases.

Qualifications

• Bachelor's degree and 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$75,804.00 - $106,940.00 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, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements
Background checks may be 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.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay