Lead Clinical Trials & Regulatory Program Manager

Jefferson Health Plans; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Thomas Jefferson University seeks a Clinical Research Project Manager to independently lead and manage clinical trials from start-up to closeout, ensuring protocol adherence and regulatory compliance across studies.

You will oversee feasibility planning, subject recruitment and retention, data and specimen management, and the development of standard operating procedures. The role may supervise staff and provide strategic guidance to research teams and departments.

Qualifications

• Bachelor's Degree required.
• Master's Degree required.
• 5+ years clinical research experience.
• 3 years clinical research experience.
• 2 years lead/Project Management experience.

Responsibilities

• Independently oversees and executes all phases of clinical trials from start-up to closeout, including feasibility assessments, protocol coordination (screening, recruiting, enrolling, consenting), data and biological specimen management, and preparation for monitoring visits, ensuring compliance with Good Clinical Practice (GCP) and all applicable regulations.
• May supervise, train, and mentor research staff, ensuring proper conduct of clinical trials, adherence to protocols, and consistent application of regulatory and institutional standards.
• Prepares, reviews, and submits regulatory and IRB documentation in a timely manner, maintains accurate study records and subject logs, tracks study finances, and performs quality control assessments to ensure integrity, accuracy, and audit readiness of clinical trial data.
• Leads or supports research operations within a division or department, contributes to and implements standard operating procedures, participates in leadership initiatives, and represents the organization internally and externally while providing expert consultation on clinical research processes and compliance.

Skills

Clinical research experience

Lead/Project Management

Education

Bachelor's Degree

Master's Degree

Job description

Thomas Jefferson University seeks a Clinical Research Project Manager to independently lead and manage clinical trials from start-up to closeout, ensuring protocol adherence and regulatory compliance across studies.

You will oversee feasibility planning, subject recruitment and retention, data and specimen management, and the development of standard operating procedures. The role may supervise staff and provide strategic guidance to research teams and departments.