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.
Key Accountabilities:
Depending on study assignment and with support as necessary key accountabilities are:
o Primary contact for assigned sites and build positive business relationships with physicians and
site staff.
o Site identification, selection and start-up activities including negotiation of site agreements
and budgets.
o Demonstrate protocol expertise.
o Customization of country/site specific documentation.
o Conduct of all remote and on-site monitoring activities through all study stages.
o Proactive issue management with a focus on issue prevention.
o Identification of potential out of scope activities.
o Perform regular reviews of data according to Site Management Plan (SMP).
Regularly inform manager, ORL and PL (as needed) of status of work.
o Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology
Practices
(GPP) guidelines, local country requirements, SOPs and study specific procedures
Qualifications
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.
• Willing to travel locally and internationally as necessary.
• Seeks opportunities to develop experience and knowledge making suggestions to enhance service
delivery.
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
This employer is a corporate member of
myGwork, the business community for LGBTQ+ professionals,
graduates, inclusive employers & anyone who believes in workplace equality.