Clinical Project Manager (relocation to Cyprus)

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​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. 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

Conditions:

• Full time, office based, office in Limassol, Cyprus
• Relocation to Cyprus, support in relocation
• Periodic business trips (EU) as Sponsor management oversight part