Kathelyne Rochas

Operational coordination of international Phase II-III clinical studies. Study Setup: operational implementation for central laboratories, logistics (samples, kits), vendors, and CROs. Management of scope changes: analysis of protocol amendments, SOW update, impact identification, and team/vendor alignment. Operational interface between sponsors, CROs, sites, and vendors. Timeline monitoring, project meeting facilitation, reporting (dashboards, KPIs). Proactive risk management and mitigation plans. Vendor supervision (central labs, logistics, data) and quality monitoring. International process harmonization and continuous improvement. Contribution to feasibility and logistical/lab assessments before launch.

Primary operational interface with sponsors: daily coordination, needs clarification, and commitment tracking. Organization and facilitation of project meetings: agendas, summaries, action item tracking, and key decision communication. Coordination of operational activities between internal teams (labs, logistics, data) and external partners. Progress monitoring: prioritization, dependency management, issue resolution, and risk alerts. Contribution to continuous improvement: workflow optimization, practice harmonization, and implementation of steering tools. Support for feasibility activities and preparation of operational documents for study launch.

Coordination of central laboratory operational activities for international clinical studies. Monitoring of samples and logistics flows: kits, supplies, transport, and compliance with protocol requirements. Daily interface with internal teams (lab, data, logistics) and global teams to ensure operational fluidity. Update and control of operational documents (SOPs, logistics plans, site instructions). Contribution to study preparation: lab requirements, sample flow alignment, and analytical timelines. Support for project teams: operational reporting, indicator monitoring, and deviation management.