Implements country clinical operations strategies to deliver portfolio and trial execution objectives in alignment with Study & Site and local business priorities
Ensures Country trial site selection, activation, enrolment, resource allocation, timelines and budget commitments are delivered per established trial objectives
Builds and maintains effective site relationship management to ensure site performance and delivery of quality monitoring
Ensures delivery of high-quality data and compliance with clinical standards, applicable regulations, and company procedures
Identifies, escalates, and resolves operational issues, including support for audits, inspections, and implementation of corrective actions
Drives adherence to quality standards and ensures consistent implementation of processes and best practices across country operations
Acts as primary point of contact for FSP/external vendors, ensuring overall quality and performance, including escalation and follow-up of non-performance
Ensures appropriate allocation and effective utilization of resources to deliver country portfolio objectives
Manages country budget and productivity in line with targets and supports continuous improvement and implementation of global processes and tools
Requirements
Bachelor’s Degree in life sciences required
Fluent in both written and spoken English
Minimum 8 years’ experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management role
Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
Thorough 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 Competencies:
Leadership, strategic thinking and matrix management skills; Established track record of leading successful teams
Excellent negotiation and conflict resolution skills; excellent organisational, interpersonal skills with extensive networking expected
Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
Preferred Requirements:
Advanced Degree in life sciences or business
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model