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Clinical Operations Lead

20 hours, 54 minutes ago
Germany
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 4

Description

  • Provide overall clinical operations oversight for a project at regional or global level.
  • Oversee assigned CRAs and investigator sites in line with the monitoring plan, protocol, GCP, ICH guidelines, and local regulations.
  • Serve as the primary liaison between CRAs and the clinical project team.
  • Deliver project-specific training, mentoring, and guidance to regional CRAs.
  • Conduct CRA assessment and co-monitoring visits to evaluate performance and compliance.
  • Prepare monitoring plans, study tools, training materials, and other study documentation for sites and CRAs.
  • Support enrollment and recruitment strategy development and implementation.
  • Review visit reports, track protocol deviations, and manage issue escalation and corrective actions.
  • Monitor site and country performance metrics, including recruitment, data collection, and document collection.
  • Support startup, feasibility, vendor management, and other clinical project team objectives as needed.

Requirements

  • College diploma/degree with 7-9 years of related experience and continuous training and skills upgrading, 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, organizational, and report-writing skills.
  • Strong understanding of GCP, ICH guidelines, local regulations, IRB/EC processes, and investigator responsibilities.
  • Ability to manage multiple tasks and deadlines in a dynamic environment.
  • Proactive, detail-oriented, task-driven, and highly organized working style.

Benefits

  • Home-based remote working arrangement.
  • Annual salary of €58,000 to €96,500.
  • Bonus opportunity.
  • Accommodations for persons with disabilities available on request.
  • Access to a human-led hiring process even when AI tools are used in recruitment.

Interested in this position?

Apply directly on the company website

Apply Now

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