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Senior Obervational Research Specialist

Parexel International Corporation

Spain - Any Region - Home Based

This position can be located at any region home-based in Spain

Job Purpose:

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. Responsible for supporting the development of the Clinical Operations service delivery within Parexel.

Key Accountabilities:

Depending on study assignment can include: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.Demonstrate protocol expertise.Customization of country/site specific documentation.Conduct of all remote and on-site monitoring activities through all study stages.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 study management system(s) on a daily basis.Coordination of a team of ORSs managing a study in a country/ region and main point of contact for the ORL.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.Coaching and mentoring of new and/ or junior staff members.Assessment of junior staff including shadow/ assessment of calls/ visits as part of ORS Certification activities.Contribution to department service delivery and participation in initiatives.QualificationsSkills:Excellent interpersonal, verbal and written communication skills in English and SpanishExcellent 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.Ability to manage complex workload (across multiple studies as necessary) and prioritize accordingly.Effectively applies knowledge to provide advice or solutions based on expertise and experience.Ability to provide support and constructive feedback to study team members and Dept. colleagues.

Knowledge and Experience:Clinical Monitoring 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.

Job posted: 2021-04-17

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