Global Clinical Operations Lead - GI Trials

Alimentiv; United States; Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Education Reimbursement program

Monthly Cell Phone and Remote Work

Office setup allowance

Working while visiting program

Flexible Summer Hours

Employee referral incentive

Trust after 1 year

Mentorship program

Job summary

Alimentiv, a global CRO focused on GI therapies, seeks a Clinical Operations Lead to provide oversight for regional or global projects, ensuring study deliverables, CRA activities and investigator sites align with protocol, monitoring plan, ICH-GCP, and local regulations. You will liaison between CRAs and the clinical project team, offering operational guidance and training.

This role supports site start-up, feasibility, recruitment strategies, monitoring performance, issue escalation, and

Qualifications

• 4–6 years of relevant clinical research experience; 7–9 years preferred.
• Minimum 3 years CRA experience with hands-on monitoring.
• Bachelor’s degree in Health Sciences or related field preferred.
• Strong understanding of ICH-GCP, local regulations, IRB/EC requirements.
• Experience with EDC systems and clinical documentation.
• Knowledge of trial processes, site management and performance metrics.
• Excellent written and verbal communication with CRAs, Sponsors and investigators.
• Strong organizational and project coordination skills.
• Proactive, detail‑oriented, problem-solving and proactive.
• Proficiency in Microsoft Office; ability to prepare high-quality reports.
• SoCRA/ACRP certification is an advantage.

Responsibilities

• Oversee regional CRAs and investigator sites for protocol compliance and study timelines.
• Conduct co-monitoring and CRA assessment visits to ensure standards.
• Monitor site performance, recruitment, data collection and TMF activities.
• Oversee regional site start-up and feasibility activities and vendor management.
• Review monitoring visit reports for quality and timely deliverables.
• Serve as key contact for CRAs and escalate issues to project management.
• Provide training and mentoring to CRAs on procedures and timelines.
• Participate in Sponsor meetings and CRA calls with progress updates.
• Develop enrolment strategies and create study tools and monitoring plans.
• Support study deliverables and financial project activities as required.

Skills

ICH-GCP knowledge

CRA experience

Regulatory compliance

Site management

Data management

Communication skills

MS Office

EDC familiarity

Project coordination

SoCRA/ACRP knowledge

Education

Bachelor’s degree in Health Sciences

Post-secondary certificate/diploma

Tools

CTMS familiarity

EDC systems

Job description

Alimentiv, a global CRO focused on GI therapies, seeks a Clinical Operations Lead to provide oversight for regional or global projects, ensuring study deliverables, CRA activities and investigator sites align with protocol, monitoring plan, ICH-GCP, and local regulations. You will liaison between CRAs and the clinical project team, offering operational guidance and training.

This role supports site start-up, feasibility, recruitment strategies, monitoring performance, issue escalation, and