Clinical Project Manager A

University of Pennsylvania; Pennsylvania; On-site; USD 63,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Tuition benefits

Retirement plans

Job summary

University of Pennsylvania in Philadelphia is seeking a Clinical Project Manager A to oversee the operational and regulatory conduct of interventional neuromodulation trials.

The group studies low-intensity focused ultrasound and deep brain stimulation for obsessive-compulsive disorder and substance use disorder, funded by NIH and philanthropic sources, conducted at Penn with collaborating sites and device partners.

Qualifications

• Bachelor's degree with 3-5 years of related experience or equivalent education/experience required.
• Experience with IRB submissions and FDA-regulated (IND/IDE) research, Good Clinical Practice, and clinical data systems strongly preferred; device trials, neuromodulation, psychiatric or neurological populations, or multi-site coordination a plus.
• Strong organization, written communication and attention to detail; ability to manage competing deadlines across several protocols.

Responsibilities

• Trial operations: manage single- and multi-site clinical research projects, start-up, daily operations, site collaboration, recruitment tracking, QA/QC, and close-out.
• Regulatory and study documentation: develop regulatory submissions and study documents, maintain regulatory binder and IDE file, and support registrations.
• Finance and grants: assist with pre- and post-award activities, NIH reporting, and budget inputs.
• Staff supervision and training: assist/train staff, onboarding, data management, protocol compliance and QA.
• Other duties as assigned.

Skills

IRB submissions

FDA-regulated research

Good Clinical Practice

clinical data systems

device trials

neuro modulation

multi-site coordination

organization

written communication

attention to detail

Education

Bachelor's degree

Job description

Clinical Project Manager A

The University of Pennsylvania, the largest private employer inPhiladelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranksamong the top 10 universities in the annual U.S. News & WorldReport survey. Penn has 12 highly-regarded schools that provideopportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach toscholarship and learning. As an employer Penn has been rankednationally on many occasions with the most recent award from Forbeswho named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city ofPhiladelphia. The University is situated on a beautiful urbancampus, with easy access to a range of educational, cultural, andrecreational activities. With its historical significance andlandmarks, lively cultural offerings, and wide variety ofatmospheres, Philadelphia is the perfect place to call home forwork and play.

The University offers a competitive benefits package that includesexcellent healthcare and tuition benefits for employees and theirfamilies, generous retirement benefits, a wide variety ofprofessional development opportunities, supportive work and familybenefits, a wealth of health and wellness programs and resources,and much more.

Posted Job Title

Clinical Project Manager A

Job Profile Title

Clinical Research Project Manager A

Job Description Summary

The Clinical Project Manager A will manage the operational andregulatory conduct of a portfolio of interventional neuromodulationtrials. The group studies low-intensity focused ultrasound and deepbrain stimulation for obsessive-compulsive disorder and substanceuse disorder, with funding from the National Institutes of Health(NIMH and NIDA) and philanthropic sources. Studies are conducted atPenn with a collaborating academic site and an industry devicepartner, and are carried out under investigator-held abbreviatedInvestigational Device Exemptions with FDA record-keeping andsafety-reporting obligations.

Under guidance from the Principal Investigator, the ClinicalProject Manager manages day-to-day operations of the clinicalresearch projects, maintains the studies' regulatory files, andserves as the principal operational point of contact with thecollaborating site, the device manufacturers and the Data andSafety Monitoring Board. The role assists with protocoldevelopment, project coordination across sites, and quality controlof data; supports grant applications and NIH progress and milestonereporting; prepares reports and presentations; contributes todissemination of study findings; and may supervise project staffand participate in study visits.

This position suits someone who wants breadth across regulatoryaffairs, trial operations and cross-institutional coordination onfirst-in-population device research, and who is comfortable holdingseveral protocols at once.

Contingent upon funding.

Job Description

Trial operations. With supervision, manage single- andmulti-site clinical research projects including study start-up,daily operations, communication with the collaborating site anddevice partner, recruitment and enrollment tracking against NIHmilestones, troubleshooting, quality assurance and quality control,and study close-out. Coordinate device delivery, training andsession scheduling with the device manufacturer; maintain deviceaccountability records. May include study visits and procedureswhen needed to meet the needs of the project.

Regulatory and study documentation. Develop, create andreview regulatory submissions and study documents and tools,including protocols, consent forms, IRB modifications andcontinuing reviews, annual reports, source documents, trainingmaterials, manuals of procedures, Data and Safety Monitoring Boardcharters and meeting packets, case report forms and standardoperating procedures. Maintain the regulatory binder and theabbreviated IDE file (21 CFR 812 records and reporting), supportsponsor-investigator registration with the Penn Medicine Office ofClinical Research, and manage ClinicalTrials.gov registration andresults reporting. Provide assistance with investigational newdrug, investigational device and clinical trial agreementdeterminations.

Finance and grants. Assist with pre-award activities(clinical trials management system registration, Medicare coverageanalysis where applicable, research billing numbers, contract andagreement timelines, budget input, grant-writing assistance) andpost-award activities (invoicing, subaward and consultant billingreview, purchasing of study equipment and supplies). Support NIHreporting, including annual progress reports (RPPR), recruitmentmilestone reports and NIMH Data Archive submissions.

Staff supervision and training. Assist and train direct andindirect clinical research staff in program, division anddepartment procedures as required per protocol, includingonboarding, data and lab management in the study's 21 CFR Part11-compliant data system (PennCRMS), protocol compliance, qualitycontrol and quality assurance, human subjects protection, GoodClinical Practice, project assignments, staff mentoring andbi-annual performance appraisal completion.

Other duties as assigned.

Qualifications

• Bachelor's degree with 3-5 years of related experience, or anequivalent combination of education and experience, is required.Experience with IRB submissions and FDA-regulated (IND/IDE)research, Good Clinical Practice, and clinical data systems isstrongly preferred; experience with device trials, neuromodulation,psychiatric or neurological populations, or multi-site coordinationis a plus. Strong organization, written communication and attentionto detail; ability to manage competing deadlines across severalprotocols. Position is contingent on continued funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$63,085.00 - $78,231.00 Annual Rate

Salary offers are made based on the candidate's qualifications,experience, skills, and education as they directly relate to therequirements of the position, and in alignment with salary rangesbased on external market data for the job's level. Internalorganization 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state or local law.

Special Requirements

Background checks may be required after a conditional job offer ismade. Consideration of the background check will be tailored to therequirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Pennoffers comprehensive medical, prescription, behavioral health,dental, vision, and life insurance benefits to protect you and yourfamily's health and welfare. You can also use flexible spendingaccounts to pay for eligible health care and dependent careexpenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuitionbenefits. You, your spouse, and your dependent children can gettuition assistance here at Penn. Your dependent children are alsoeligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans tohelp you save for your future. Penn's Basic, Matching, andSupplemental retirement plans allow you to save for retirement on apre-tax or Roth basis. Choose from a wide variety of investmentoptions through TIAA and Vanguard.
• Time Away from Work: Penn provides you with asubstantial amount of time away from work during the course of theyear. This allows you to relax, take vacations, attend to personalaffairs, recover from illness or injury, spend time withfamily-whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with GenworthFinancial, Penn offers faculty and staff (and your eligible familymembers) long-term care insurance to help you cover some of thecosts of long-term care services received at home, in the communityor in a nursing facility. If you apply when you're newly hired, youwon't have to provide proof of good health or be subject tounderwriting requirements. Eligible family members must alwaysprovide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed tosupporting our faculty and staff as they balance the competingdemands of work and personal life. That's why we offer a widevariety of programs and resources to help you care for your health,your family, and your work-life balance.
• Professional and Personal Development: Penn provides anarray of resources to help you advance yourself personally andprofessionally.
• University Resources: As a member of the Penn community,you have access to a wide range of University resources as well ascultural and recreational activities. Take advantage of theUniversity's libraries and athletic facilities, or visit ourarboretum and art galleries. There's always something going on atPenn, whether it's a new exhibit at the Penn Museum, the latestmusic or theater presentation at the Annenberg Center, or the PennRelays at Franklin Field to name just a few examples. As a memberof the Penn community, you're right in the middle of theexcitement-and you and your family can enjoy many of theseactivities for free.
• Discounts and Special Services: From arts andentertainment to transportation and mortgages, you'll find greatdeals for University faculty and staff. Not only do Penn arts andcultural centers and museums offer free and discounted admissionand memberships to faculty and staff. You can also enjoysubstantial savings on other goods and services such as new carsfrom Ford and General Motors, cellular phone service plans, movietickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offercreative approaches for completing work while promoting balancebetween work and personal commitments. These approaches involve useof non-traditional work hours, locations, and/or jobstructures.
• Penn Home Ownership Services: Penn offers a forgivableloan for eligible employees interested in buying a home orcurrently residing in West Philadelphia, which can be used forclosing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligibleemployees on qualified expenses in connection with the legaladoption of an eligible child, such as travel or court fees, for upto two adoptions in your household.

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

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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state, or local law.

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