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パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Observational Research Specialist

求人ID 65561BR ロケーション ミラノ, Lombardia 仕事内容
Observational Research Specialist provides site management for observational/non-interventional research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:
◦Site identification
◦Negotiation of site agreements and budgets
◦Collection and review of regulatory documents for EC and RA submissions
◦Customization of informed consent
◦Site management


Key Accountabilities
•Primary contact for assigned sites
•Perform site start-up activities
•Demonstrate protocol expertise
•Conduct remote visits (initiation, monitoring, termination)
•Train team members on selected tasks
•Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC,IVRS, ISIS)
•Responsible for the completeness and quality of the in-house site specific files (in cooperation with ROA/RMA)
•Update all relevant tracking systems on an ongoing basis
•Follow-up on appropriate site related questions.

Qualifications

Skills
•Sound interpersonal, oral and written communication skills
•Strong computer skills including Clinical Trial Management Systems, Electronic records, EDC, MS-Office products such as Excel, Word and PowerPoint.
•Strong awareness of all relevant regulations, including GCP and GPP
•Ability to successfully work in a (‘virtual’) team environment
•Strong knowledge of observational/non-interventional study research
•Sound problem solving and analytical skills
•Strong customer focus, ability to interact professionally within a client organization and with study sites
•Willing and able to travel as required – local or international.

Education
•Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience

Language Skills
•Fluent in written and oral Italian nd English.

Minimum Work Experience
•Previous clinical monitoring (on-site or remote) data management and/ or research experience with a solid understanding of observational/non-interventional research methodology and terminology
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