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Clinical Study Manager

#FD75784
Type: Full time
FUICS Development Ltd.

FUICS is a state of the art Biotech development company transforming pharmaceuticals from pre-clinical stage to commercial readiness.

We are looking for a motivated individual as a Clinical Study Manager. As a fast-growing Biotech, the job offers great potential for personal development and growth.

Job Purpose

The Clinical Study Manager (CSM) is accountable for performance and compliance for assigned protocols in EU / US countries in compliance with ICH/GCP and country regulations, company policies and procedures, and quality standards. The person is responsible for the execution and oversight of clinical trials conduct from RA/EC CTA preparation to CSR delivery.

Responsibilities:

  • Participation in creation and review of clinical trial documentation such as study protocols, ICFs, study manuals, plans etc.
  • Manages country deliverables, timelines and results for assigned protocols to meet country commitments
  • Clinical trial site feasibility, selection, routine monitoring, and close-out oversight including co-monitoring as applicable
  • Ensures CRA oversight, provides training as required or contributes as Subject Matter Expert
  • Responsible for quality and compliance for the assigned protocols
  • Contributes to the development of the clinical operations department's SOPs
  • Interaction, communication, management, and oversight of third-party vendors
  • Participation in preparations of audits at third parties, provide support and oversight to local vendors, as applicable
  • Clinical trial logistic and supplies management
  • Participation in preparation of documents and in interactions with RAs
  • Proper maintenance of clinical trials documentation and relevant databases. Plan and track all clinical activities and monitor all lifecycle of trials
  • Preparation and participation in audits/inspections, as applicable

Requirements:

  • Higher education: Medicine/Biology/Pharmacology/Chemistry
  • 6+ years of experience in clinical trials management, including international trials
  • People management and third-party vendors management experience
  • In-depth understanding and experience in the clinical trial process: monitoring, management, medical writing (preferable) and RA/EC submission

We are looking forward to receiving CVs directly to hr@fuics.com

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