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Clinical Operations Lead

1 month ago
Poland
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 assigned regional or global projects.
  • Manage and support CRAs to ensure protocol, GCP, ICH, and local regulatory compliance.
  • Serve as the primary liaison between CRAs, the clinical project team, and study sponsors.
  • Conduct monitoring support visits and CRA assessment visits as needed.
  • Prepare and maintain monitoring plans, training materials, study tools, and other project documentation.
  • Oversee site startup, feasibility, recruitment, and enrollment activities.
  • Review visit reports, track protocol deviations, and escalate issues with corrective actions.
  • Support site, country, and CRA performance management through metrics, status updates, and coaching.
  • Assist with vendor management and other cross-functional project deliverables, including data management and TMF-related activities.
  • Contribute to financial project management tasks such as site payments and expense review, where applicable.

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.
  • Minimum of 3 years of CRA experience.
  • Health Sciences, Life Sciences, or Nursing background preferred.
  • SoCRA and/or ACRP certification or designation preferred.
  • Strong experience with EDC systems.
  • Proficiency with MS Office.
  • Strong written and verbal communication skills.
  • Highly effective interpersonal, organizational, and report-writing skills.
  • Strong understanding of GCP, local regulations, IRB/EC, and investigator responsibilities.
  • Ability to manage multiple tasks and deadlines in a dynamic environment.

Benefits

  • Full-time, permanent position.
  • Remote, home-based working arrangement.
  • Accommodation support available for persons with disabilities upon request.
  • Opportunity to work on regional/global clinical studies with cross-functional exposure.

Interested in this position?

Apply directly on the company website

Apply Now

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