Clinical Operations Manager (relocation to Cyprus)

Clinical Operations Manager (relocation to Cyprus)

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​FUICS is looking for a motivated individual as a Clinical Operations Manager. As a fast-growing Biotech, the job offers great potential for personal development and growth.

Job Purpose

The Clinical Operations Manager (COM) 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. In collaboration with a Clinical Project Manager the person is responsible for the management 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, budgets and results for assigned protocols to meet country commitments
• Clinical trial sites feasibility, selection, routine monitoring, and close-out oversight including co-monitoring as applicable
• Ensures CRA oversight
• Responsible for quality and compliance for the assigned protocols
• Interaction, communication, management, and oversight of third party-vendors
• Clinical trial logistic and supplies management
• Proper maintenance of clinical trials documentation and relevant databases
• Preparation and participation in audits/inspections, as applicable
• Standard operating procedures preparation and review (as applicable)

Requirements:

• Higher education: Medicine/Biology/Pharmacology/Chemistry
• 6+ years of experience in the conduct of clinical 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