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Clinical Operations Manager
hace 2 meses
As a Clinical Operations Manager at Novasyte, you will be responsible for managing the execution of assigned clinical studies from initiation to closeout. Your primary goal will be to ensure that clinical study management and project deliverables are completed on time and in accordance with standard operating procedures (SOPs), policies, and practices.
Key Responsibilities:
- Provide project-related support and assistance across multiple projects, sites, and teams.
- Review structured clinical data output with access to medical charts.
- Ensure work is conducted as per SOPs, policies, and Good Clinical Practice (GCP) guidelines.
- Develop and use study management plans and/or risk-based monitoring specific tools and templates.
- Support project management teams to develop monitoring strategies, including monitoring triggers/thresholds.
- Manage operational insights of assigned projects and complete study/site metrics trending.
- Perform remote monitoring visits for assigned sites.
- Conduct Subject Level Data Review and perform further investigation with clinical sites as required.
- Develop and contribute to new analytics proposals based on customer demands.
- Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements.
- Identify value adds from centralized review and remote monitoring in studies.
- Support CMS leads to perform oversight on clinical deliverables.
- Collaborate and support project resources, including CRAs, CTAs, and Centralized Monitoring teams.
- Ensure complete and accurate documentation of site-specific tools and templates.
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity.
- Manage triggers and prepare i-site packs for respective sites and countries.
- Conduct periodic review of site-level Key Risk Indicators (KRIs) and historic site performance.
- Monitor site performance and make recommendations for timely corrective actions.
- Review the effectiveness of recommended actions and take additional actions if necessary.
- Work in accordance with the Study Central Monitoring Plan.
- Establish and maintain effective project/site-level communications with relevant stakeholders.
- Provide mentorship to Associate Central Monitors.
- Review reports, identify issues, and escalate them to the Clinical Lead.
- Prepare annotations and conduct CRA trainings.
- Attend Kick-Off meetings, weekly team meetings, and other relevant meetings.
