Global Clinical Operations Lead (Remote)

Logoslabs; San Francisco (CA); Remote; USD 120,000 - 170,000; Full time

Job summary

Logoslabs is seeking a Clinical Operations Lead to oversee a regional/global group of CRAs and Investigator sites, ensuring adherence to study protocol, ICH-GCP, local regulations, and study timelines. You will mentor CRAs, coordinate site visits, and manage monitoring plans and reports.

The role involves training, performance oversight, escalation of issues, and collaboration with the study team on enrollment strategies, site selection, and vendor management.

Qualifications

• College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
• Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Responsibilities

• Overall oversight of regional CRAs to ensure site compliance with study protocol, plans, ICH-GCP, local regulations and study timelines.
• Monitoring support visits (Co-monitoring) to aid site/CRA in satisfactory performance and compliance.
• May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
• Oversee regional startup and feasibility activities.
• Assist in vendor management activities as required per project.
• Perform review of visit reports for quality, compliance and appropriate site management.

Skills

CRA experience

EDC systems

MS Office

Communication skills

Interpersonal skills

Organizational skills

Education

College diploma/degree

Undergraduate university degree (Bachelors or Honors)

Job description

Logoslabs is seeking a Clinical Operations Lead to oversee a regional/global group of CRAs and Investigator sites, ensuring adherence to study protocol, ICH-GCP, local regulations, and study timelines. You will mentor CRAs, coordinate site visits, and manage monitoring plans and reports.

The role involves training, performance oversight, escalation of issues, and collaboration with the study team on enrollment strategies, site selection, and vendor management.