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Clinical Operations Lead

1 month ago
Romania
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

  • Provide overall clinical operations oversight for a project across a defined regional or global scope.
  • Oversee assigned CRAs and investigator sites to ensure compliance with the protocol, monitoring plan, GCP, ICH guidelines, and local regulations.
  • Act as the primary liaison between CRAs and the clinical project team.
  • Conduct and support project-specific CRA training, mentoring, and assessment visits.
  • Implement and support enrollment and recruitment strategies with the clinical project team.
  • Prepare monitoring plans and other study-specific documentation and tools for sites and CRAs.
  • Review visit reports, track protocol deviations, and manage issue escalation and corrective actions.
  • Monitor site, country, and CRA performance metrics, including recruitment, data collection, document collection, and TMF review.
  • Support regional startup and feasibility activities, vendor management, and other cross-functional project deliverables as needed.
  • Attend sponsor and project meetings to provide status updates and operational guidance.

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.
  • A Health Sciences, Life Sciences, or Nursing specialty is preferred.
  • SoCRA and/or ACRP certification or designation is 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.
  • Ability to prepare reports and critically understand clinical research documents.
  • Ability to manage multiple tasks and meet deadlines in a dynamic environment.

Benefits

  • Home-based work arrangement.
  • Full-time, permanent position.
  • Accommodation support available for persons with disabilities during the recruitment and selection process.

Interested in this position?

Apply directly on the company website

Apply Now

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