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Biotech
Lead clinical trial projects from site selection through study close-out, serving as primary client contact. Oversee cross-functional teams, vendors, budgets, timelines, risk management, site training, recruitment, safety reporting, eTMF/CTMS maintenance, and audit/inspection readiness while ensuring compliance with ICH GCP, local regulations, SOPs and Project Agreement.
Biotech
Reviews, amends, negotiates, and executes Clinical Trial Agreements with research sites. The role ensures contracts comply with legal requirements, internal policies, and negotiation parameters while supporting timely clinical trial start-up and maintenance. Responsibilities include managing contract workloads, assessing risks, escalating issues, coordinating with Project Management, Regulatory, Clinical Operations, Finance, Legal, study teams, clients, and sites, and facilitating company signatory execution.
Biotech
Leads clinical development project delivery for the CNS/Neuroscience therapeutic area, overseeing portfolios, client relationships, business growth, financial performance, risk management, regulatory compliance, and resource allocation. Manages and develops senior project management leaders, drives strategic planning and operational excellence, and serves as executive sponsor for major accounts. Ensures projects meet timeline, budget, quality, ICH-GCP, and client satisfaction objectives.
