Region US Head Trial Monitoring Operations Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Region US Head Trial Monitoring Operations job in East Hanover

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Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  249008BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  East Hanover
Map: 
09/05/2018

Description
The Region Head is accountable for all 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 within the Region (250+ protocols , 5000 + patients patients per year). Is responsible for the delivery of data within timelines and to the required quality standards. Provides functional management of Monitoring groups of the Countries in the Region (400+ associates, internal and externals). The Region Head is responsible for achieving budget targets and contributing to the delivery of the productivity targets. Is responsible for implementing the Trial Monitoring strategy in the Region and for the implementation of and adherence to established Monitoring procedures in accordance with GCP, ICH and local regulations.
Trial Monitoring Strategy • Drives Trial Monitoring Strategy to achieve Global and Regional/Local business objectives in close interaction with Global Head Trial Monitoring, Regional CSO and Medical Director • Drives innovation in clinical trial planning and execution, including patient engagement as appropriate • Aligns Trial Monitoring Objectives with Regional and Country objectives Allocation, initiation and conduct of trials • Defines and implements feasibility and allocation strategies and execution of global develop-ment trials in Region (Innovative Medicines Phase I-IV clinical trials - 250+ trials, 5000+patients per year) • Optimally utilizes Regional opportunities and builds competitive advantages for global devel-opment trials within the Region taking into account medical standard of care, competitive environment and local business drivers • Ensures trials execution is according to enrolment commitment, timelines and budget; tracks performance through key performance indicators; drives Regional re-allocation or corrective action when needed Delivery of quality data and compliance to quality standards • Supervises Monitoring quality KQIs in the Region's CPOs, ensures clinical data standards • Ensures issues are escalated and manages escalated issues; if quality issues dictate super-vises resulting CPO CAPAs • Monitors adherence/compliance to SOPs and required training curricula • Develops an understanding of the prevailing legislation, GCP, Ethical Committee, and SOP requirements within the Region interacting with Country Heads/MDs, GLFs, DevQA • Drives continuous improvement in operations and fosters best practice sharing within and across the regions Management of people and resources management • Ensures strong functional line management to Trial Monitoring Country Heads, monitors, and support staff (400+ internals and externals); hires Trial Monitoring Country Heads • Is responsible for the allocation of Trial Monitoring and FSP resources among Monitoring structures in the Region in co-operation with Global Head, Trial Monitoring and local Medical organization • Ensures the development and implementation of the global training strategy within the Re-gion; ensures Regional and Country needs are communicated and met through the Global Monitoring Training team • Sets targets and objectives and manages performance of Trial Monitoring associates together with leadership team Budget and productivityBachelor's Degree in life sciences required; Advanced Degree in scientific or business preferred English • At least 10 years' experience in clinical research, in planning/executing and/or monitoring clinical trials with at least 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/EMEA), local/National Health Authorities regulations and Novartis standards • Superior leadership skills, strategic thinking skills and matrix management skills • Established track record of leading successful teams, preferably with experience in working with international teams • Excellent negotiation and conflict resolution skills • Excellent organisational and interpersonal skills required, extensive networking expected • Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
ref: (249008BR)
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