Global Clinical Operations - SSO Hong Kong Manager job opportunity at Novartis.

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DatePosted 30+ Days Ago bot
Novartis Global Clinical Operations - SSO Hong Kong Manager
Experience: General
Pattern: full-time
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degreeAssociate
loacation Hong Kong, Hong Kong
loacation Hong Kong....Hong Kong

Job Description Summary The SSO Hong Kong Manager is accountable for all clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of clinical trials. The SSO Hong Kong Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to 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 Hong Kong 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 Development trial delivery.   Job Description Key responsibilities: Implements the defined Study & Site Operations and  Hong Kong 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 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 Hong Kong 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

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