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Biotech
Lead and manage clinical trials from site selection to closeout, ensuring compliance with ICH GCP and local regulations, meeting timelines and budgets, coordinating cross-functional teams, vendors, data and safety activities, and maintaining project documentation (CTMS/eTMF). Act as primary client contact and drive recruitment, risk mitigation, and audit readiness.
Biotech
Lead global IT service delivery and Enterprise Service Management (ESM), manage regional service teams, own ServiceNow, enforce SLAs/KPIs, implement QA and compliance frameworks, oversee incident/problem/request/knowledge processes, drive continuous improvement and automation, manage budgets and stakeholder reporting, and ensure regulatory validated system adherence.
Biotech
Support start-up phase of clinical trials by preparing, submitting, and tracking country- and site-level ethics and regulatory authority applications per ICH-GCP and local requirements. Act as contact for sites, manage submission timelines, respond to reviewer queries, and advise project leads on local regulations to enable timely approvals.
