Global Clinical Operations Lead — GI Trials

Alimentiv; Newark (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Education Reimbursement program

Cell Phone and Remote Work Allowance

Office setup allowance

Visiting program – up to 4 weeks per y

Flexible Summer Hours Program

Employee referral incentive

Alimentiv Trust eligibility

Job summary

Alimentiv is seeking a Senior Clinical Operations Lead to provide regional and global operations oversight for GI-related clinical trials. You will guide monitoring, site management, and start-up activities, coordinating with Clinical Project Management, CRAs, and cross-functional teams to ensure protocol adherence, data integrity, and timely delivery.

The role requires extensive experience in clinical research, leadership capabilities, and strong knowledge of ICH-GCP and regulatory

Qualifications

• 7–9 years of clinical research experience; 10+ preferred.
• 3+ years hands-on CRA experience; 2+ years COL or equivalent leadership experience.
• Bachelor’s degree in a relevant discipline; equivalentExperience considered.

Responsibilities

• Provide regional/global clinical operations oversight across assigned studies, ensuring compliance with protocols and timelines.
• Lead and oversee COLs and CRAs, providing guidance, training and operational support.
• Oversee monitoring and site management deliverables, including visit schedules and recruitment progress.
• Lead country/site feasibility and start-up activities, providing input into strategies.
• Serve as liaison between monitoring team, project management and Sponsors, escalating risks.
• Develop and maintain study-specific docs and tools (Monitoring Plans, training materials).
• Review monitoring reports and metrics to ensure quality and on-time delivery.
• Lead CRA/COL meetings and participate in Sponsor meetings and Investigator Meetings.
• Support budget oversight, including visit forecasts and site payments.
• Mentor COLs and other clinical operations colleagues.

Skills

Clinical ops leadership

CRA experience

Project coordination

ICH-GCP knowledge

Regulatory compliance

EDC systems

Communication skills

Budget oversight

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Alimentiv is seeking a Senior Clinical Operations Lead to provide regional and global operations oversight for GI-related clinical trials. You will guide monitoring, site management, and start-up activities, coordinating with Clinical Project Management, CRAs, and cross-functional teams to ensure protocol adherence, data integrity, and timely delivery.

The role requires extensive experience in clinical research, leadership capabilities, and strong knowledge of ICH-GCP and regulatory