Clinical Operations Compliance Leader | Inspection-Ready Excellence

Apex Systems, LLC; Cambridge, Northern (MA, KY); Hybrid; USD 152,000 - 207,000; Full time

Job summary

Everforth Apex Systems in Cambridge, MA seeks an Associate Director/Director of Clinical Operations Compliance for a contract role overseeing standards across clinical programs. You will partner with Clinical Operations, Quality, Regulatory, and Data Sciences to ensure inspection readiness and robust compliance processes.

The role requires a strong background in GCP/ICH, FDA/EMA expectations, and leadership of multi-disciplinary teams to drive scalable governance and global regulatory readiness.

Qualifications

• 10+ years in biotech, pharmaceutical, or CRO environments.
• 8+ years in clinical operations with leadership experience.
• Strong knowledge of GCP, ICH, FDA, and EMA requirements.
• Experience driving SOP development, TMF governance, and vendor oversight.

Responsibilities

• Lead clinical operations compliance initiatives and standards.
• Drive SOP, work instruction, and TMF governance programs.
• Ensure inspection readiness through training and continuous improvement.
• Partner cross-functionally to support quality and compliance objectives.
• Provide compliance oversight for trial management, vendor oversight, and study closeout.

Skills

Leadership

Regulatory compliance

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Everforth Apex Systems in Cambridge, MA seeks an Associate Director/Director of Clinical Operations Compliance for a contract role overseeing standards across clinical programs. You will partner with Clinical Operations, Quality, Regulatory, and Data Sciences to ensure inspection readiness and robust compliance processes.

The role requires a strong background in GCP/ICH, FDA/EMA expectations, and leadership of multi-disciplinary teams to drive scalable governance and global regulatory readiness.