Summary
The SSO Country Manager is responsible for monitoring integration within Country CSO and Medical Director to ensure alignment on portfolio strategy, prioritization, and performance to aligned objectives for GDD trial delivery
About the Role
Key responsibilities:
Your responsibilities include, but are not limited to:
- Implements the defined Study & Site Operations and OPC country structure monitoring strategies to deliver country business and trial strategy objectives in close collaboration with the SSO Cluster Head Portfolio, Clinical Research Associate (CRA) Manager and Country CSO and Medical Director
- Aligns Country monitoring objectives to the SSO Country Head (OPC) and country CSO/Medical Director
- Identifies and implements innovative practices and patient engagement strategies in collaboration with Clinical Research Associate (CRA) Manager, Country CSO and Medical Director within the country to advance clinical trial planning, execution, and quality
- Responsible for the alignment between SSO Feasibility Manager and relevant medical/clinical functions to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV trials)
- Drives collaborative engagement model with Cluster Head Portfolio to ensure Country participation in GDD trials is aligned with the overall OPC Country structure portfolio execution strategy
- Actively monitors the KQI’s and develops, maintains and follows-up on the yearly process control plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Actively manages Country issue identification and resolution in relation to CPO and trial audits, inspections and delivers to CAPA implementation requirements
- Along with FSP/BiS line manager is responsible for selection of CRAs, Study Start-up CRAs and enabling function associates
Essential Requirements:
- Bachelor’s Degree in life sciences required; Advanced Degree in life sciences or business preferred
- Relevant years of experience in clinical research - planning/executing and/or monitoring clinical trials with few years in a people management role
- Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
- Understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Excellent organizational, interpersonal skills with extensive networking
- Excellent negotiation and stakeholder management skills
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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