Clinical Operations Specialist
hace 4 semanas
Novasyte is seeking a highly skilled Clinical Operations Specialist to manage the execution of clinical studies from initiation to closeout.
Key Responsibilities- Ensure clinical study management and project deliverables are on time and in accordance with standard operating procedures (SOPs), policies, and practices.
- Provide project-related support and assistance across multiple projects, sites, and teams, and review structured clinical data output with access to medical charts.
- Develop and use study management plans and/or risk-based monitoring specific tools and templates to evaluate the quality and integrity of the study.
- Support project management teams to develop monitoring strategies, including monitoring triggers and thresholds.
- Manage the operational insight of assigned projects and complete study/site metrics trending (trend analysis of clinical aspects of the trial, share trends, and agree on action plans).
- Review the effectiveness of recommended actions and take appropriate additional actions if no effect is observed.
- Work in accordance with the Study Central Monitoring Plan, establishing and maintaining effective project/site-level communications with relevant stakeholders.
- Provide mentorship to Associate Central Monitors, reviews reports per annotations, SOPs, guidelines, identifies issues, and escalates them to Clinical Leads.
- Analyze the complexity of requirements and provide EAC hours and turn-around times.
- Review the Study Central Monitoring Plan and attend Kick-Off meetings, weekly team meetings, and other project-related meetings.
Essential Functions:
- Manage assigned sites and perform Subject Level Data Review independently.
- Perform remote monitoring visits for assigned sites as assigned.
- Perform Study-specific analytics based on applicable study-specific plans.
- Contribute to developing new analytics proposals as per customer demand.
- Manage the operational insight of assigned sites/studies and complete the study/site metrics trending.
- Identify value adds from the centralized review & remote monitoring in the study and provide inputs to relevant stakeholders.
- Support CMS Leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines, and project Clinical Operations Plan.
- Collaborate and support project resources (CRAs/CTAs/Centralized Monitoring Team).
- Ensure complete and accurate documentation of all site-specific tools and templates and keep sites audit-ready.
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs, respective regulation, and guidelines.
- Manage triggers and prepare i-site packs for respective sites and countries for assigned studies.
- Perform activities delegated and/or act as a backup for/to relevant stakeholders within the project team.
- Conduct periodic reviews of site-level KRIs and historic site performance according to the Central Monitoring Plan and provide inputs to CMS Leads to enable early identification of site-level risk/issues.
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