Clinical Operations Lead

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Accountable for overseeing the clinical operations of a project at a specified regional or global level.

• Ensures the management of project deliverables, supervises Clinical Research Associates (CRAs), and coordinates with Investigator sites in alignment with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.

• Serves as the primary contact between the CRAs and the clinical project team.

• Additional duties encompass project-specific training for CRAs, conducting assessment visits alongside CRAs, implementing enrollment and recruitment strategies, preparing the monitoring plan and relevant structural documentation, and managing the scheduling of monitoring visits, site performance metrics, issue escalation, and corrective actions.

• The COL will create study tools for both site and CRA utilization, review visit reports, track protocol deviations, and assist in achieving other objectives for clinical operations and the clinical project team.

⛳️ Requirements

• College diploma or degree with 7-9 years of related experience, plus ongoing training and skills enhancement.

• OR An undergraduate university degree (Bachelors or Honors Bachelors) along with 4-6 years of experience, plus significant continuous job-related training.

• Preference for candidates with a specialty in Health Sciences, Life Sciences, or Nursing, or those holding SoCRA and/or ACRP Certification/Designation.

• A minimum of 3 years of CRA experience is required, with strong proficiency in EDC systems, MS Office, and exceptional written and verbal communication skills, alongside highly effective interpersonal and organizational abilities.

• Must exhibit the following characteristics: proactive, detail-oriented, task-driven, and exceptionally organized.

• Must demonstrate a solid understanding of GCPs and local regulations as they pertain to clinical monitoring, IRB/EC, and Investigator responsibilities.

• Proven skills in report writing and a strong ability to critically interpret clinical research documents.

• Capable of managing multiple tasks to meet deadlines in a fast-paced environment.

🏝️ Benefits

• Accommodations for individuals with disabilities are available upon request throughout all phases of the recruitment and selection process.

• Requests can be sent to recruitment@alimentiv.com.