Novotech
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Biotech
Leads multinational clinical trial teams, coordinating site selection, monitoring, training, recruitment, safety reporting, data quality, regulatory compliance, risk management, and timely study deliverables. Develops clinical management plans, reviews monitoring reports, oversees clinical documentation, and collaborates with project managers, sponsors, vendors, and regulatory teams. The role also mentors clinical staff and supports operational improvements across complex clinical studies.
Biotech
Lead and manage oncology clinical trial projects from site selection through closeout. Oversee timelines, budgets, vendors, regulatory/ethics submissions, patient recruitment, safety coordination, eTMF/CTMS maintenance, and ensure compliance with ICH‑GCP, SOPs and Project Agreements.
Biotech
Manages Data Management staff, resource allocation, recruitment, onboarding, performance, and professional development. Provides expert oversight of clinical data management deliverables, technical solutions, process improvements, system validation, project budgets, timelines, quality, audits, proposals, and sponsor interactions. Leads biometrics support activities, training initiatives, cross-functional collaboration, and bid defenses while ensuring clinical studies comply with GCP, regulatory requirements, SOPs, and project agreements.
