Clinical Project Manager – Neurodevice Trials (NIH)

Opportunity for Health; Philadelphia (Philadelphia County); Hybrid; USD 63,000 - 78,000; Full time

Job summary

University of Pennsylvania in Philadelphia, PA, seeks a Clinical Project Manager A to oversee operational and regulatory conduct of interventional neuromodulation trials, including ultrasound and deep brain stimulation research funded by NIH and other sources.

You will coordinate across sites and device partners, manage regulatory documents and IDE files, support grant activities, and contribute to data quality and reporting while supervising staff as needed.

Qualifications

• IRB submissions experience and FDA-regulated (IND/IDE) research preferred.
• Strong GCP knowledge and experience with clinical data systems.
• Experience with device trials, neuromodulation 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.
• 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.

Skills

IRB submissions

Good Clinical Practice

Regulatory affairs

Trial operations

Education

Bachelor’s degree

Job description

University of Pennsylvania in Philadelphia, PA, seeks a Clinical Project Manager A to oversee operational and regulatory conduct of interventional neuromodulation trials, including ultrasound and deep brain stimulation research funded by NIH and other sources.

You will coordinate across sites and device partners, manage regulatory documents and IDE files, support grant activities, and contribute to data quality and reporting while supervising staff as needed.