Clinical Project Manager A

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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 and regulatory conduct of a portfolio of interventional neuromodulation trials. The group studies low-intensity focused ultrasound and deep brain stimulation for obsessive-compulsive disorder and substance use disorder, with funding from the National Institutes of Health (NIMH and NIDA) and philanthropic sources. Studies are conducted at Penn with a collaborating academic site and an industry device partner, and are carried out under investigator-held abbreviated Investigational Device Exemptions with FDA record-keeping and safety-reporting obligations.

Under guidance from the Principal Investigator, the Clinical Project Manager manages day-to-day operations of the clinical research projects, maintains the studies’ regulatory files, and serves as the principal operational point of contact with the collaborating site, the device manufacturers and the Data and Safety Monitoring Board. The role assists with protocol development, project coordination across sites, and quality control of data; supports grant applications and NIH progress and milestone reporting; prepares reports and presentations; contributes to dissemination of study findings; and may supervise project staff and participate in study visits.

This position suits someone who wants breadth across regulatory affairs, trial operations and cross-institutional coordination on first-in-population device research, and who is comfortable holding several protocols at once.

Contingent upon funding.

Job Description

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

Regulatory and study documentation. Develop, create and review regulatory submissions and study documents and tools, including protocols, consent forms, IRB modifications and continuing reviews, annual reports, source documents, training materials, manuals of procedures, Data and Safety Monitoring Board charters and meeting packets, case report forms and standard operating procedures. Maintain the regulatory binder and the abbreviated IDE file (21 CFR 812 records and reporting), support sponsor-investigator registration with the Penn Medicine Office of Clinical Research, and manage ClinicalTrials.gov registration and results reporting. Provide assistance with investigational new drug, investigational device and clinical trial agreement determinations.

Finance and grants. Assist with pre-award activities (clinical trials management system registration, Medicare coverage analysis where applicable, research billing numbers, contract and agreement timelines, budget input, grant-writing assistance) and post-award activities (invoicing, subaward and consultant billing review, purchasing of study equipment and supplies). Support NIH reporting, including annual progress reports (RPPR), recruitment milestone reports and NIMH Data Archive submissions.

Staff supervision and training. Assist and train direct and indirect clinical research staff in program, division and department procedures as required per protocol, including onboarding, data and lab management in the study’s 21 CFR Part 11-compliant data system (PennCRMS), protocol compliance, quality control and quality assurance, human subjects protection, Good Clinical Practice, project assignments, staff mentoring and bi-annual performance appraisal completion.

Other duties as assigned.

Qualifications

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