Job Overview
Under the direction and guidance of the Real World Late Phase Research Site Management Lead, Line Manager or Project Manager, apply clinical research experience and skills to engage site management/monitoring staff to ensure process and practice methodology is applied consistently and in accordance with project scope and budget, SOPs, policies, good clinical practices and applicable regulatory requirements.
Under the direction and guidance of the Real World Late Phase Research Site Management Lead, Line Manager or Project Manager, apply clinical research experience and skills to engage site management/monitoring staff to ensure process and practice methodology is applied consistently and in accordance with project scope and budget, SOPs, policies, good clinical practices and applicable regulatory requirements.
Essential Functions
- Oversee the work of assigned site management staff, providing advice and guidance to help achieve quality deliverables on site.
- Assist with the development of Site Recruitment, SPS Operations and SPS Risk Management Plans.
- Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per contract.
- Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress. Report progress to appropriate SPS management and project management leaders.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Provide input and updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables.
- Act as the first line of escalation for site management questions and issues for their assigned projects.
- Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
- May act as site visit report reviewer.
- May conduct monitoring and/or assessment visits as needed to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
Qualifications
- Bachelor’s Degree in a health care or other scientific discipline
- 1 – 3 years of clinical research experience (monitoring, regulatory, CTA)
- Advanced English level
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
