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Sr. Clinical Operations Lead

3 weeks, 4 days ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 25

Description

  • Oversee clinical operations for a project at a defined regional or global level.
  • Manage regional CRAs and investigator sites to ensure compliance with the protocol, monitoring plan, GCP, ICH guidelines, and local regulations.
  • Serve as the primary liaison between CRAs and the clinical project team.
  • Provide project-specific training, mentoring, and operational guidance to regional CRAs.
  • Conduct CRA assessment visits and monitoring support visits as required.
  • Prepare, implement, and maintain monitoring plans, structural documentation, training materials, and study tools for sites and CRAs.
  • Oversee enrollment, recruitment, startup, and feasibility activities for the region.
  • Review visit reports, protocol deviations, and site performance metrics, and escalate issues with corrective actions as needed.
  • Support vendor management, financial project management, and other cross-functional study deliverables as applicable.
  • Represent the project in sponsor meetings, kickoff meetings, investigator meetings, and site initiation or qualification visits.

Requirements

  • College diploma/degree with 7-9 years of related experience and continuous training, or an undergraduate degree with 4-6 years of experience and substantial ongoing job-related training.
  • Health Sciences, Life Sciences, or Nursing specialty preferred.
  • SoCRA and/or ACRP certification/designation preferred.
  • Minimum of 3 years of CRA experience.
  • Strong experience with EDC systems.
  • Proficiency with MS Office.
  • Strong written and verbal communication skills.
  • Highly effective interpersonal and organizational skills.
  • Experience understanding and applying GCP, local regulations, IRB/EC, and investigator responsibilities.
  • Ability to write reports, critically review clinical research documents, manage multiple tasks, and meet deadlines in a dynamic environment.

Benefits

  • Remote home-based working arrangement.
  • $86,000 - $143,000 annual salary.
  • Bonus eligibility.
  • Accommodations for persons with disabilities available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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