Rwe Site Managers
hace 2 meses
Job Overview
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
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