Clinical Operations Manager (relocation to Cyprus)
You are kindly asked to provide the CV in English.
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
