SSO Study Start-Up Team Lead Warsaw, Masovian Voivodeship

SSO Study Start-Up Team Lead
Warszawa
Warszawa, Województwo mazowieckie, Poland

-Oversees the strategic and operational planning/ management from a clinical trial execution perspective. Oversight of budget and resource allocation within assigned trial. Enables operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs.

-Manage all operational aspects of assigned clinical trials / projects -Accountable for quality & completeness of qualification & governance documentation
-Provide mentorship/coaching -Identify training needs & prepare/develop adequate training materials
-Ensures trial site selection, activation, enrolment, resource allocation, timelines & budget commitments are delivered per established trial objectives
-Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
-Distribution of marketing samples (where applicable) The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Operations Management and Execution Financial Management Collaborating across boundaries Critical Negotiations
Fluent English