FUICS is 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. Under the oversight of the Head of Product Development, the person is responsible for the execution and oversight of clinical trial conduct from RA/EC submissions to CSR delivery.

Responsibilities

• Participation in creation and review of clinical trial documentation such as TMF, 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 regulatory bodies.
• Proper maintenance of clinical trials documentation and relevant databases. Plan and track all clinical activity and monitor all lifecycle of trials.
• Preparation and participation in audits/inspections, as applicable.

Qualifications

• Higher educations: Medicine/Biology/Pharmacology/Chemistry
• 3+ years of experience in the conduct of clinical trials, including international trials
• People management and third-party vendor 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