Global Clinical Operations Lead — GI Trials (Remote Options)

Alimentiv; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Education Reimbursement program for e

Monthly Cell Phone and Remote Work Al

Office setup allowance

Working while visiting program

Flexible Summer Hours

Employee referral incentive

Alimentiv Trust participation

Alimentorship mentorship program

Regional social events

Job summary

Alimentiv, a global CRO focused on GI therapeutics, seeks a Senior Clinical Operations Lead to provide global trial oversight across monitoring and site management. You will work with CP management, CRAs, COLs and cross-functional teams to ensure protocol alignment and timely delivery.

The role requires extensive clinical research experience, leadership skills, and strong regulatory knowledge. Enjoy broad trial responsibilities, training duties, and opportunities for mentorship within a

Qualifications

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

Responsibilities

• Provide regional/global clinical operations oversight across assigned studies, ensuring compliance with protocols, Monitoring Plans, ICH-GCP and timelines.
• Lead and oversee COLs and CRAs, providing study-specific guidance, training and mentoring.
• Oversee monitoring and site management deliverables, including visit schedules, reports and essential documents.
• Lead country/site feasibility, selection and start-up activities with input into strategies.
• Represent Monitoring & Site Management in sponsor meetings and provide trial management support.
• Develop and maintain study operational documentation and tools (Monitoring Plans, training materials, enrolment strategies).
• Review monitoring reports and metrics to ensure quality and timely delivery.
• Lead CRA/COL meetings and participate in sponsor/investigator meetings as required.
• Support project and monitoring budget oversight and resource planning.

Skills

Clinical operations leadership

CRA experience

ICH-GCP knowledge

Regulatory knowledge

Cross-functional collaboration

Budget oversight

EDC systems

Microsoft Office

Education

Bachelor’s degree

Equivalent experience considered

Tools

EDC systems

Microsoft Office

Job description

Alimentiv, a global CRO focused on GI therapeutics, seeks a Senior Clinical Operations Lead to provide global trial oversight across monitoring and site management. You will work with CP management, CRAs, COLs and cross-functional teams to ensure protocol alignment and timely delivery.

The role requires extensive clinical research experience, leadership skills, and strong regulatory knowledge. Enjoy broad trial responsibilities, training duties, and opportunities for mentorship within a