Observational Research Specialist Ii

7 mesi fa

Milano, Italia Parexel A tempo pieno

**Parexel **is currently looking for an Observational Research Specialist II to join the team in Italy.**

**This role can be either office-based in Milan or decentralized in Italy**

The **Observational Research Specialist II (ORS II)** independently provides site management and supports activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations.

**Key Accountabilities**:

- Primary contact for assigned sites and build positive business relationships with physicians and site staff.
- Site identification, selection and start-up activities including negotiation of site agreements and budgets.
- Customization of country/site specific documentation.
- Conduct of all remote and on-site monitoring activities through all study stages.
- Proactive issue management with a focus on issue prevention.
- Perform regular reviews of data according to Site Management Plan (SMP).
- Responsible for the completeness and quality of the site files for the assigned sites.
- Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures.

**Skills**:

- Excellent interpersonal, verbal and written communication skills in English.
- Excellent customer focus and able to interact professionally with a client organization and study site.
- Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial Management and EDC systems.
- Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP.
- Ability to work in a 'virtual' team environment as well as work independently, seeking guidance as appropriate.
- Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.
- Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.
- Willing to travel locally and internationally as necessary.

**Knowledge and Experience**:

- Clinical Monitoring, Data Management and/or research experience with a solid understanding of Observational/ Non-interventional research methodology and terminology.

**Education**:

- Degree in a life science, nursing qualification or other relevant experience required.

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