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Site Management Associate I
2 meses atrás
We are seeking a highly skilled and experienced Site Management Associate I to join our team at ICON. As a Site Management Associate I, you will play a critical role in ensuring the successful execution of clinical trials.
Key Responsibilities- System Setup and Maintenance: Set up and maintain systems and tracking tools to ensure quality, consistency, and integration of study data, following up on discrepancies if needed. Grant access to new system users.
- Quality and Data Oversight: Support study lead in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination).
- Study Team Communication: Support in managing the study team's communication: meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists, etc.
- Study Budget Management: Coordinate of the study budget – managing expenses, tracking updates, checking consistency between systems and agreements, and escalating issues.
- Process Development: Providing input to develop study-specific processes and procedures, adhering to standardization and dissemination of best practices.
- Document Preparation: May be involved in preparation and updating of study documents and study plans, including Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans, etc.
- Vendor Management: May act as Local Operating Companies liaison/oversight – including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies' availability, regulatory approvals, and import license status.
- Clinical Supplies Management: May be involved in clinical supplies and recruitment materials management – having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate.
- Risk Management: May contribute to Risk management – contribution to maintenance of a comprehensive risk management plan and risk tracking.
- Education: Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required.
- Experience: Experience working with Global Teams.
- Language Skills: Advanced English Skills.
- System Knowledge: Knowledge/experience on systems is relevant (VEEVA and others).
- Budget Management: Budget Management knowledge is relevant.
