Clinical Project Manager A
About The Position
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.
Requirements
- 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.
- Strong organization, written communication and attention to detail; ability to manage competing deadlines across several protocols.
Nice To Haves
- Experience with device trials, neuromodulation, psychiatric or neurological populations, or multi-site coordination is a plus.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts for health care and dependent care expenses
- Exceptional tuition benefits for employee, spouse, and dependent children
- Generous retirement plans (Basic, Matching, and Supplemental)
- Substantial amount of time away from work
- Long-term care insurance
- Wellness and work-life resources
- Professional and personal development resources
- Access to a wide range of University resources, cultural and recreational activities
- Discounts and special services (arts, entertainment, transportation, mortgages, etc.)
- Flexible work hours
- Penn Home Ownership Services
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
