Study Start Up Specialist/ GSS Specialist II - Budapest, Hungary
Study Start Up Specialist (GSS Specialist) oversees and manages the study start up phase of regional clinical trials. Responsibilities typically include contributing to the development and management of budgets, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. The GSS Specialist also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data.
Education / Qualifications
• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
• In lieu of the above requirement, candidates with four or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Minimum of four 4 years of relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start up.
• Comprehensive understanding of applicable regional regulatory requirements.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Excellent verbal and written communication skills.
• Ability to lead and develop junior staff.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work within a project team.
• Ability to work efficiently and effectively in a matrix environment.
• 1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience, especially regarding study start up.
Lead core project team during study start up phase and facilitate team's ability to lead extended/complete project team; depending on size and scope of project.
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