Clinical Research Project Manager

Insight Global; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

Insight Global seeks a Clinical Research Project Manager to lead clinical trials from activation through closeout, ensuring adherence to GCP and regulatory standards. The role involves coordinating with the Study Start-Up team to support feasibility, activation readiness, and study planning.

The position also entails supervising and mentoring research staff, maintaining essential documentation and submissions, and driving quality control and process improvements across the department.

Qualifications

• Experience managing clinical trials in compliance with GCP and regulatory standards.
• Ability to supervise, train and mentor research staff while ensuring protocol adherence.
• Strong data and regulatory documentation management skills.

Responsibilities

• Oversees trial operations from activation to closeout, including screening, recruitment, data/specimen management.
• Partners with Study Start-Up to support feasibility, planning, and activation readiness.
• Supervise, train, and mentor staff, ensuring adherence to protocols and regulatory requirements.
• Maintains study documentation, regulatory submissions, financial tracking, and quality control processes.
• Supports departmental operations, contributes to SOP development and process improvements.

Education

Bachelor's degree in life sciences

Tools

EDC systems

Regulatory submissions software

Job description

The Clinical Research Project Manager leads and manages clinical trials through study execution and closeout, ensuring compliance with protocol requirements, institutional standards, and regulatory guidelines. This role provides operational oversight of research activities, including participant recruitment and retention, data and specimen management, and regulatory compliance. The Project Manager collaborates with the Study Start-Up team to support study initiation and ensure a smooth transition into study conduct. The role may also supervise research staff, drive process improvements, and provide guidance on clinical research operations and compliance.

Responsibilities:

• Oversees clinical trial operations from study activation through closeout, including participant screening, recruitment, enrollment, consenting, data and specimen management, and preparation for monitoring visits, ensuring compliance with GCP and applicable regulations.
• Partners with the Study Start-Up team to support feasibility assessments, study planning, and activation readiness.
• Supervise, train, and mentor research staff, ensuring adherence to protocols, regulatory requirements, and institutional policies.
• Maintains study documentation, regulatory submissions, financial tracking, and quality control processes to ensure data integrity and audit readiness.
• Supports departmental research operations, contributes to process improvements and SOP development, and serves as a resource on clinical research processes and compliance.