Clinical Trials Manager - Pulmonary Translational Research

University of Pittsburgh; Pittsburgh (Allegheny County); Hybrid; USD 80,000 - 115,000; Full time

Benefits offered by this job

Remote work options

Hybrid work model

Job summary

The University of Pittsburgh is seeking a Clinical Trials Manager for the Pulmonary Translational Research Core to oversee regulatory activities, budgeting, and multi-site coordination for industry and government trials.

You will draft and submit IRB protocols, manage contracts with sponsors, and partner with investigators and coordinators to ensure compliant, timely study execution; remote-friendly hybrid work is available.

Qualifications

• Regulatory coordinator with a minimum of 3 years of regulatory and budgeting experience with industry and government sponsored clinical trials.
• Drafting, submission, and management of IRB protocols, budgeting for clinical trials, management of industry sponsored clinical trial documentation.
• Experience with University of Pittsburgh and UPMC clinical trials infrastructure (SCTP, Pitt IRB, Advarra OnCore) is also a plus.

Responsibilities

• Draft and submit protocols to Pitt and external IRB’s
• Budgeting for industry and government sponsored clinical studies
• Management of industry sponsored clinical trial documentation
• Utilization of electronic clinical trial management systems (OnCore and sponsor based)
• Interaction with clinical trial sponsors, auditors, monitors and IRB staff.
• Coordination of monitoring and site initiation visits
• Support of principal investigators and clinical research coordinators

Skills

IRB submissions

Budgeting

Regulatory coordination

Clinical trials coordination

Interpersonal collaboration

Education

Bachelor's degree

Tools

OnCore

Pitt IRB

SCTP

Job description

The University of Pittsburgh is seeking a Clinical Trials Manager for the Pulmonary Translational Research Core to oversee regulatory activities, budgeting, and multi-site coordination for industry and government trials.

You will draft and submit IRB protocols, manage contracts with sponsors, and partner with investigators and coordinators to ensure compliant, timely study execution; remote-friendly hybrid work is available.