Sr. Clinical Operations Lead

Clinical Operations Lead – Make a Difference in Clinical Research

Are you a seasoned clinical research professional passionate about leading and mentoring clinical research associates? Alimentiv is seeking a dynamic Clinical Operations Lead (COL) to oversee the clinical operations of a project within a regional or global scope. If you thrive in a collaborative environment and have a strong understanding of GCP guidelines, ICH guidelines, and local regulations, we encourage you to apply!

Key Responsibilities: Ensuring Study Integrity & Site Success

As a Clinical Operations Lead, you’ll be the crucial link between our Clinical Research Associates (CRAs) and the clinical project team, ensuring the smooth and compliant execution of clinical trials. Your responsibilities will include:

• Project Oversight: Overseeing a team of regional CRAs, guaranteeing site compliance with study protocols, plans, ICH-GCP guidelines, and local regulations.
• Monitoring Support: Providing co-monitoring visits (as required) to guide sites and CRAs towards achieving optimal performance and adherence to standards.
• Cross-Functional Collaboration: Potentially supporting the clinical project team by overseeing study deliverables related to other departments (e.g., Data Management, TMF Operations).
• Start-up & Feasibility: Supervising regional study startup and feasibility activities.
• Vendor Management: Assisting in vendor management activities as required by the project.
• Quality Assurance: Conducting thorough reviews of visit reports to ensure quality, compliance, and effective site management.
• Proactive Management: Actively managing site and country performance metrics (recruitment, data collection, document collection, TMF review, etc.) and providing updates to the clinical project team.
• Financial Contribution: Contributing to financial project management processes (e.g., revenue recognition, site payments, site pass-through expense review).

Project Liaison: Bridging the Gap Between CRAs and Project Success

You’ll be the go-to person for ensuring smooth communication and efficient operations:

• CRA Communication: Facilitating regular global CRA calls, as well as individual/country CRA calls, to keep the monitoring and site management team aligned.
• Sponsor Interaction: Attending meetings with Study Sponsors to provide status updates on country and site progress.
• Operational Support: Providing operational support and guidance to the monitoring team throughout the project lifecycle.
• Training & Mentoring: Delivering project training and mentorship to regional CRAs on study procedures, clinical plans, guidelines, and timelines.
• Issue Resolution: Serving as the first point of contact for regional CRAs regarding study-specific questions and issues, escalating appropriately.
• Performance Monitoring: Supporting line managers by providing updates on CRA utilization and performance.
• CRA Assignment: Liaising with line managers to assign sites to CRAs based on resource allocation.
• Assessment Visits: Conducting CRA assessment visits to evaluate performance against monitoring responsibilities.

Study Documents and Plans: Contributing to a Solid Foundation

Your expertise will be critical in developing essential study resources:

• Developing training materials and study tools for sites and CRAs, including robust monitoring plans.
• Collaborating with the clinical project team to develop and implement effective enrolment and recruitment strategies.
• Developing and delivering presentations for Sponsor Kickoff meetings, Investigator meetings, and Sponsor Calls.
• Preparing presentations for Site Qualification Visits and Site Initiation Visits.

Qualifications: Your Expertise is Our Asset

We’re looking for someone with a strong foundation in clinical research and excellent leadership skills:

• Option 1: College diploma/degree AND 7-9 years of related experience with continuous training and knowledge/skills upgrading.
• Option 2: Undergraduate university degree (Bachelor’s or Honors Bachelor’s) AND 4-6 years of relevant experience with substantial on-going job-related training.
• Health Sciences, Life Sciences, or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
• Minimum 3 years of CRA experience.
• Proficiency with EDC systems and MS Office.
• Excellent written and verbal communication skills, as well as highly effective interpersonal and organizational skills.
• Proactive, detail-oriented, task-driven, and highly organized.
• Strong understanding of GCPs and local regulations related to clinical monitoring, IRB/EC, and Investigator responsibilities.
• Demonstrated ability in report writing and critical understanding of clinical research documents.
• Ability to handle multiple tasks and meet deadlines in a dynamic environment.

Working Conditions

This is a home-based position.

Alimentiv is committed to providing accommodations for persons with disabilities throughout the recruitment and selection process. Requests can be directed to recruitment@alimentiv.com.

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