Observational Research Specialist Ii Milano

Observational Research Specialist Ii
Milano
Lombardia, Milano

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.