Clinical Trials Project Lead: Operations & Compliance

Insight Global; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a Clinical Research Project Manager to lead trials from activation to closeout, ensuring protocol compliance and regulatory standards. You will oversee consent, recruitment, data management, and monitoring preparation, while coordinating with the Study Start-Up team for smooth initiation.

The role requires 5+ years of clinical research experience (or 3+ with a Master’s) and hands-on experience with interventional trials, SAEs/AEs, and team leadership in oncology

Qualifications

• Bachelor's degree with 5+ years of clinical research experience OR Master's degree with 3+ years of clinical research experience.
• Experience supporting patient-facing interventional drug trials.
• Experience overseeing clinical trial operations, including protocol development, study management, and coordination across the study lifecycle.
• Direct experience working with research participants/patients.
• Prior people management experience, including coaching, performance reviews, and team development.

Responsibilities

• Lead and manage clinical trials through study execution and closeout, ensuring protocol and regulatory compliance.
• Provide operational oversight of research activities, including participant recruitment and retention, data and specimen management, and regulatory compliance.
• Collaborate with Study Start-Up team to support study initiation and activation readiness.
• Maintain study documentation, regulatory submissions, financial tracking, and quality control processes.

Skills

Clinical research experience

GCP compliance

Regulatory compliance

People management

Oncology experience

Education

Bachelor's degree

Master's degree

Job description

Insight Global is seeking a Clinical Research Project Manager to lead trials from activation to closeout, ensuring protocol compliance and regulatory standards. You will oversee consent, recruitment, data management, and monitoring preparation, while coordinating with the Study Start-Up team for smooth initiation.

The role requires 5+ years of clinical research experience (or 3+ with a Master’s) and hands-on experience with interventional trials, SAEs/AEs, and team leadership in oncology