Обязанности:
You are kindly asked to provide the CV in English. 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 educations: Medicine/Biology/Pharmacology/Chemistry 3+ years of experience in the conduct of clinical trials, 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 partПохожие вакансии