Observational Research Specialist II (Bi-lingual French/English)

As an Observational Research Specialist II, you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations.

Key Accountabilities:

Depending on study assignment and with support as necessary key accountabilities can include:

• Act as 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.

• Demonstrating protocol expertise.

• Customization of country/site specific documentation.

• Conducting of all remote and on-site monitoring activities through all study stages.

• Proactive issue management with a focus on issue prevention.

• Identification of potential out of scope activities.

• 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.

• Maintaining study management system(s) on a daily basis.

• Regularly inform manager, ORL and PL (as needed) of status of work.

• 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 (and local language as necessary).

• 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.

• Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery.

• Willingness to travel LOCALLY and NATIONALLY up to 30% when necessary.

Knowledge and Experience:

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

• Fluent in French Language-speaking and writing REQUIRED.

Education:

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