Full-Time Senior CRA and Local Trial Manager (Budapest)
Our innovative Pharma client is looking for an experienced clinical research professional to join their team in the following role:
Senior CRA and Local Trial Manager
• Site administrating and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP;
• Act as Local Trial Manager in certain trials and review the work of assigned CRAs
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
• Completing Serious Adverse Event (SAE) reporting, processing production of reports;
• Negotiating study budgets with potential investigators and assisting the legal department with statements of agreements as assigned;
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring.
Required skills, experience:
• Strong understanding of the clinical trial process
• Minimum 4 years of relevant clinical research experience (clinical on-site monitoring experience) in pharmaceutical or CRO companies
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Fluency in Hungarian and English language.
Our Client can offer dynamic work environment and opportunity to gain experience in clinical trial management.
Job reference: 1202148
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