Global Clinical Operations Lead — Remote Options

Alimentiv; North Carolina; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Education Reimbursement program

Monthly Cell Phone and Remote Work – (

Office setup allowance

Visiting program – up to 4 weeks per y

Job summary

Alimentiv, a global CRO focused on GI therapies, is seeking a Senior Clinical Operations Lead to provide regional and global operations leadership across trials. This role works with Clinical Project Management, COLs, CRAs, and cross-functional teams to ensure studies meet protocol, ICH-GCP, and timelines, including country/site start-up, monitoring, enrolment, and reporting.

You will oversee trial lifecycle activities, mentor COLs and CRAs, and contribute to process improvements while

Qualifications

• 7–9 years in clinical research; 10+ years preferred.
• 3+ years hands-on CRA experience and 2+ years COL or equivalent leadership experience.
• Bachelor’s degree in a relevant discipline; an equivalent combination of education and experience may be considered.
• Strong knowledge of ICH-GCP, clinical monitoring requirements, IRB/EC processes, Investigator responsibilities and local regulations.
• Experience with EDC systems and MS Office.

Responsibilities

• Provide regional/global oversight across studies, ensuring protocol and regulatory compliance.
• Lead COLs and CRAs, providing study-specific guidance, training, mentoring and operational support throughout the project lifecycle.
• Oversee monitoring plans and site management deliverables, including visit schedules, recruitment progress, essential document collection and protocol adherence.
• Lead country/site feasibility, start-up activities, and input into country/site strategies.
• Represent Monitoring & Site Management in sponsor meetings and kickoff discussions; escalate risks.
• Support budget oversight and resource planning for projects.

Skills

Clinical ops leadership

Project management

ICH-GCP knowledge

Monitoring & site management

CRA/COL guidance

Budget oversight

Communication

Education

Bachelor's degree in life sciences

Tools

EDC systems

Microsoft Office

Job description

Alimentiv, a global CRO focused on GI therapies, is seeking a Senior Clinical Operations Lead to provide regional and global operations leadership across trials. This role works with Clinical Project Management, COLs, CRAs, and cross-functional teams to ensure studies meet protocol, ICH-GCP, and timelines, including country/site start-up, monitoring, enrolment, and reporting.

You will oversee trial lifecycle activities, mentor COLs and CRAs, and contribute to process improvements while