Alimentiv
Clinical Study Delivery - Monitoring & Site Management
Sr.ClinicalOperationsLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Clinical Operations Lead at Alimentiv. Skills: Clinical operations, Project oversight, Site management, CRA management. Provide oversight of project deliverables. Oversee assigned Clinical Research Associates”
What You'll Achieve.
Ensure site compliance; Ensure timely project deliverables; Manage site performance; Manage country performance
Industry & Context.
Issue escalation; Corrective actions
Home-based
What They're Looking For.
Must Have
College diploma/degree and 7-9 years related experience, Undergraduate university degree and 4-6 years' experience, Minimum 3 years CRA experience, Experience with EDC systems, Proficient with MS Office, Written and verbal communication skills, Highly effective interpersonal skills, Highly effective organizational skills, Demonstrate GCPs and local regulations knowledge, Ability to handle multiple tasks
Nice to Have
Health Sciences, Life Sciences or Nursing specialty, SoCRA and/or ACRP Certification/Designation
What You'll Do.
Provide oversight of project deliverables
Oversee assigned Clinical Research Associates
Oversee Investigator sites
Ensure compliance with Monitoring Plan
Ensure compliance with Protocol
Ensure compliance with GCP
Ensure compliance with ICH guidelines
Ensure compliance with local regulations
Act as primary liaison between CRAs and project
Provide project specific training of CRAs
Conduct assessment visits with CRAs
Implement enrollment strategies
Implement recruitment strategies
Prepare monitoring plan
Prepare structural documentation
Oversee monitoring visit scheduling
Oversee site performance metrics
Oversee monitoring performance metrics
Manage issue escalation
Manage corrective actions
Develop study tools for site use
Develop study tools for CRA use
Review protocol deviations
Track protocol deviations
Support clinical operations objectives
Support clinical project team objectives
Ensure site compliance with study protocol
Ensure site compliance with study plans
Ensure site compliance with ICH-GCP
Ensure site compliance with local regulations
Ensure site compliance with study timelines
Support monitoring support visits
Aid site in satisfactory performance
Aid CRA in satisfactory performance
Provide oversight of study deliverables
Oversee regional startup activities
Oversee feasibility activities
Assist in vendor management activities
Assure compliance with high quality deliverables
Assure compliance with timely project deliverables
Manage site performance
Manage country performance
Inform clinical project team on progress
Contribute to financial project management
Input on revenue recognition
Input on site payments
Input on site pass-through expense review
Manage investigator sites
Oversee investigator sites
Conduct global CRA calls
Conduct country CRA calls
Attend meetings with Study Sponsor
Provide status updates on country progress
Provide status updates on site progress
Provide operational support to monitoring team
Provide guidance to monitoring team
Provide project training to regional CRAs
Provide mentoring to regional CRAs
Ensure study specific training requirements completed
Ensure study specific training requirements documented
Act as first point of contact for CRAs
Escalate issues to PM
Escalate issues to other functions
Support line managers with status updates
Provide status updates on CRA utilization
Provide status updates on CRA performance
Liaise with line manager for assigning sites
Conduct CRA Assessment visits
Assess CRA performance against responsibilities
Develop training materials for sites
Develop training materials for CRAs
Develop presentation materials for Sponsor Kickoff meetings
Develop presentation materials for Investigator meetings
Develop presentation materials for Sponsor Calls
Prepare presentations for Site Qualification Visits
Prepare presentations for Site Initiation Visits
How You'll Work.
Team & Collaboration
Clinical project team; Monitoring and site management team; Study Sponsor meetings; Line managers; Other functions
Communication Scope
Written communication; Verbal communication; Status updates; Presentations
Process & Methodology
Monitoring Plan, Protocol, GCP, ICH guidelines, Local regulations, Project timelines, Study plans, Enrollment strategies, Recruitment strategies, Site qualification, Site initiation
Full Job Description
## Description Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team. ## Project Oversight Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines. Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above. 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. Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan. Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress. Con
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