Global Clinical Operations Lead - Home-Based

Alimentiv

Washington (District of Columbia)

On-site

USD 90,000 - 130,000

Full time

5 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

Alimentiv is seeking a Clinical Operations Lead (COL) to oversee a group of regional CRAs and monitor site performance within a defined regional/global scope. You will coordinate CRA activities, ensure compliance with ICH-GCP, GCP, and local regulations, and support enrollment strategies and monitoring plans.

This role requires strong CRA experience, expertise with EDC systems, and excellent communication skills.

Qualifications

Minimum 3 years CRA experience.
Strong experience with EDC systems.
Proficient with MS Office.
Excellent written and verbal communication; interpersonal and organizational skills.
Demonstrates knowledge of GCPs and local regulations.

Responsibilities

Oversee regional CRAs to ensure site compliance with study protocol, ICH-GCP, local regulations and timelines.
Provide co-monitoring support visits to aid site/CRA performance and compliance.
Support the clinical project team with oversight of study deliverables and regional startup/feasibility activities.
Provide training and mentorship to regional CRAs on procedures and timelines.
First point of contact for CRA questions; escalate when needed.
Assist line managers with CRA utilization and performance updates.
Track site assignment to CRAs and conduct CRA assessment visits.