Global Clinical Operations Lead

Alimentiv-2; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Education reimbursement

Cell phone allowance

Remote work allowance

Office setup allowance

Visiting program

Flexible hours

Referral incentive

Alimentiv Trust

Mentorship program

Country/region events

Job summary

Alimentiv in San Diego, CA seeks a Clinical Operations Lead to oversee regional/global projects, ensuring study deliverables and regulatory compliance. You will liaise between CRAs and the clinical project team, guiding operations, training, and oversight throughout the study.

The role covers site start-up, feasibility, recruitment strategies, monitoring, issue escalation, and documentation, shaping overall project delivery.

Qualifications

• 4–6 years of relevant clinical research experience required; 7–9 years preferred.
• Minimum 3 years of CRA experience with hands-on monitoring.
• Post-secondary certificate/diploma; a Bachelor’s degree in Health Sciences, Life Sciences, Nursing or related discipline is preferred.
• Strong understanding of ICH-GCP, local regulations, IRB/EC requirements and Investigator responsibilities.
• Experience with EDC systems and clinical research documentation.
• Excellent written and verbal communication and project coordination skills.
• SOCRA and/or ACRP certification/designation is an advantage.

Responsibilities

• Provide oversight of regional CRAs and investigator sites, ensuring compliance with study protocols and timelines.
• Conduct co-monitoring and CRA assessment visits to support performance.
• Monitor recruitment, data collection, TMF activities, and communicate progress to the team.
• Oversee site start-up and feasibility activities and vendor management as needed.
• Review monitoring visit reports for quality and compliance.
• Provide study-specific training and mentoring to CRAs.
• Participate in sponsor meetings and CRA calls with updates on progress.

Skills

Clinical monitoring

ICH-GCP

Regulatory knowledge

Communication skills

Project coordination

MS Office

EDC systems

Site management

Problem solving

Training delivery

Education

Bachelor’s degree

Health Sciences

Nursing

Tools

EDC systems

Job description

Alimentiv in San Diego, CA seeks a Clinical Operations Lead to oversee regional/global projects, ensuring study deliverables and regulatory compliance. You will liaise between CRAs and the clinical project team, guiding operations, training, and oversight throughout the study.

The role covers site start-up, feasibility, recruitment strategies, monitoring, issue escalation, and documentation, shaping overall project delivery.