Job Description Summary

The SSO Country Manager is accountable for all country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The SSO Country Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site and local business objectives. Operationally responsible for building a high performing team culture and including performance management and established monitoring procedures in accordance with GCP, ICH and local regulations.
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

Job Description

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

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model