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Clinical Operations Lead

1 month ago
Hungary
Full-time
Lead
Project 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 regional or global level.
  • Manage and support regional CRAs to ensure compliance with study protocol, ICH-GCP, local regulations, and project timelines.
  • Act as the primary liaison between CRAs and the clinical project team.
  • Conduct co-monitoring and CRA assessment visits as required.
  • Provide project-specific training, mentoring, and operational guidance to CRAs.
  • Prepare and implement monitoring plans, study tools, and other project documentation.
  • Develop and support enrollment and recruitment strategies with the clinical project team.
  • Review visit reports, track protocol deviations, and manage issue escalation and corrective actions.
  • Monitor site, country, and CRA performance metrics and communicate progress to the project team.
  • Support startup, feasibility, vendor management, and other cross-functional clinical operations activities as needed.

Requirements

  • College diploma/degree with 7-9 years of related experience plus continuous training and knowledge/skills upgrading, or an undergraduate university degree with 4-6 years of experience plus substantial ongoing job-related training.
  • Minimum of 3 years of CRA experience.
  • Health Sciences, Life Sciences, or Nursing specialty 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 and organizational skills.
  • Knowledge of GCP, local regulations, IRB/EC, and Investigator responsibilities as they relate to clinical monitoring.
  • Ability to write reports, understand clinical research documents, and manage multiple tasks in a dynamic environment.

Benefits

  • Home-based remote working arrangement.
  • Accommodation support available for persons with disabilities during the recruitment and selection process.
  • Opportunity to work on regional or global clinical study delivery.
  • Potential to contribute to cross-functional project activities across clinical operations, data management, and TMF operations.

Interested in this position?

Apply directly on the company website

Apply Now

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