Clinical Program Lead: Multi-Site Trials & Compliance

Meharrry Medical College; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Meharry Medical College Center of Excellence for Clinical and Translational Research seeks a Clinical Program Manager to lead delivery of multisite studies, including FDA-regulated trials, from start-up to close-out. You will manage cross-functional teams, maintain quality, and ensure budgets and timelines are met while complying with SOPs and regulatory requirements.

Responsibilities include developing program goals, overseeing budgets, training staff in GCP, and coordinating with sponsors and

Qualifications

• Knowledge of clinical research principles, GCP, and human subject protection regulations.
• Familiarity with FDA regulations, ICH guidelines, HIPAA, and regulatory policies.
• Experience with budgeting, financial oversight, and contract compliance.
• Strong leadership, project management, and cross-functional collaboration.
• Ability to manage multiple trials and prioritize deadlines.
• Experience with IRB submissions and regulatory processes.

Responsibilities

• Lead delivery of clinical studies from start-up to close-out.
• Serve as liaison between Meharry Medical College and sponsors/customers.
• Oversee day-to-day operations of trials and ensure on-time, in-budget deliverables.
• Develop program goals, budgets, and SOPs for the Beacon of HOPE initiative.
• Train staff in GCP and ensure regulatory compliance across sites.
• Review, monitor, and report trial progress and performance metrics.

Skills

GCP knowledge

FDA regulations

Project management

Budgeting & financial oversight

Leadership & team-building

Cross-functional collaboration

Regulatory submissions (IRB)

Multisite trial management

Communication skills

CTMS / regulatory systems knowledge

Education

Bachelor's degree in health/life sciences or related field

Tools

MS Office (Excel, Word, PowerPoint)

Smartsheet

CTMS

Outlook

Job description

Meharry Medical College Center of Excellence for Clinical and Translational Research seeks a Clinical Program Manager to lead delivery of multisite studies, including FDA-regulated trials, from start-up to close-out. You will manage cross-functional teams, maintain quality, and ensure budgets and timelines are met while complying with SOPs and regulatory requirements.

Responsibilities include developing program goals, overseeing budgets, training staff in GCP, and coordinating with sponsors and