Global Clinical Ops Lead for GI Trials

Alimentiv; Jacksonville (FL); On-site; USD 140,000 - 185,000; Full time

Benefits offered by this job

Education Reimbursement program for 
全

Monthly Cell Phone and Remote Work 
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Office setup allowance

Working while visiting program

Flexible Summer Hours Program

Employee referral incentive

Alimentiv Trust eligibility

Mentorship program (Alimentorship)

Country/region social events

Job summary

Alimentiv is seeking a Senior Clinical Operations Lead to provide regional and global operational leadership for GI clinical trials. You will supervise COLs and CRAs, ensure adherence to monitoring plans, regulatory requirements, and timelines, and guide country/site start-up, enrolment and metrics across studies.

The role requires experience in clinical operations leadership, strong communication, and familiarity with EDC systems, with opportunities to mentor teams and contribute to

Qualifications

• Approximately 7–9 years of relevant clinical research experience; 10+ years is preferred.
• Minimum of 3 years of hands-on CRA experience and 2 years of COL or equivalent clinical operations leadership experience.
• Bachelor’s degree in a relevant discipline preferred; an equivalent combination of education and relevant clinical research experience may be considered.
• Strong knowledge of ICH‑GCP, clinical monitoring requirements, IRB/EC processes, Investigator responsibilities and applicable local regulations.
• Demonstrated experience providing operational oversight across clinical studies, including monitoring, site management, study start‑up and study‑level deliverables.
• Strong experience reviewing monitoring reports, clinical research documentation, protocol deviations, study metrics and operational risks.
• Experience working with EDC systems and proficiency with Microsoft Office applications.
• Strong written and verbal communication skills with the ability to work effectively with CRAs, COLs, project teams, Sponsors and other cross‑functional stakeholders.

Responsibilities

• Provide regional and/or global clinical operations oversight across assigned studies, ensuring compliance with study protocols, Monitoring Plans, ICH‑GCP, applicable regulations and project timelines.
• Lead and oversee Clinical Operations Leads (COLs) and CRAs, providing study‑specific guidance, training, mentoring and operational support throughout the project lifecycle.
• Oversee key monitoring and site management deliverables, including monitoring visit schedules and reports, recruitment progress, essential document collection, protocol deviations and compliance with the Monitoring Plan.
• Lead and support country and site feasibility, selection and start‑up activities, providing Monitoring & Site Management input into country and site strategies.
• Serve as a key liaison between the monitoring team, Clinical Project Management, cross‑functional study teams and Sponsors, escalating risks and issues and supporting appropriate corrective actions.
• Develop and maintain study‑specific operational documentation and tools, including Monitoring Plans, CRA/site training materials, study tools and enrolment and recruitment strategies.
• Review monitoring visit reports and study performance metrics to ensure quality, consistency, appropriate site management and timely delivery.
• Lead CRA/COL meetings and represent Monitoring & Site Management during Sponsor meetings, study kick‑offs, Investigator Meetings and other project discussions as required.

Skills

Clinical research experience

CRA experience

COL leadership

ICH-GCP knowledge

IRB/EC processes

Regulatory familiarity

EDC systems

Microsoft Office

Cross-functional collaboration

Operational oversight

Education

Bachelor’s degree or higher in a relevant discipline

Tools

EDC systems

Microsoft Office

Job description

Alimentiv is seeking a Senior Clinical Operations Lead to provide regional and global operational leadership for GI clinical trials. You will supervise COLs and CRAs, ensure adherence to monitoring plans, regulatory requirements, and timelines, and guide country/site start-up, enrolment and metrics across studies.

The role requires experience in clinical operations leadership, strong communication, and familiarity with EDC systems, with opportunities to mentor teams and contribute to