Global Clinical Operations Lead

Regulatory Jobs; United States; Remote; USD 90,000 - 160,000; Full time

Job summary

Parexel is seeking a Clinical Operations Manager (COM)/COM-F/COM-R to oversee country study management, regulatory submissions, and budget oversight in the United States. The role ensures ICH-GCP compliance and aligns with HQ and local regulators to meet country milestones.

You will lead cross-functional teams of CRMs, CRAs, CTAs, and finance partners, drive start-up processes, manage contracts, and support governance while maintaining high quality and ethical standards in a remote-enabled world.

Qualifications

• Formal degree in life sciences or related field.
• Experience in clinical operations and regulatory submissions.
• Strong leadership and budget management skills.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Manage country deliverables, timelines and results for protocols.
• Oversee clinical trial coordinators and liaise with CRMs/CRAs.
• Coordinate submissions, budgets, CTRAs and local milestones.
• Collaborate with HQ to align country timelines and vendor oversight.
• Ensure compliance with ICH-GCP and regulatory requirements.

Skills

Coordination

Budget management

Regulatory submissions

Leadership

Risk management

Communication

Remote collaboration

Education

Bachelor's degree in life sciences

Tools

Clinical trial management systems

ICH-GCP knowledge

IRB/IEC interaction

Job description

Parexel is seeking a Clinical Operations Manager (COM)/COM-F/COM-R to oversee country study management, regulatory submissions, and budget oversight in the United States. The role ensures ICH-GCP compliance and aligns with HQ and local regulators to meet country milestones.

You will lead cross-functional teams of CRMs, CRAs, CTAs, and finance partners, drive start-up processes, manage contracts, and support governance while maintaining high quality and ethical standards in a remote-enabled world.