Field Monitoring Head US Region, Trial Monitoring (Remote)

322123BR
USA

Job Description

350+ trials, about 25.000+ patients per year! You will have the oversight and project management of the global monitoring operational aspects of clinical trial execution across the entire Global Drug Development (GDD) portfolio. Our aspiration is to support the global Novartis development portfolio by recruiting patients for our clinical trials, ensuring that the right patient gets into the right trial in the right country.

The Field Monitoring Head, Trial Monitoring, will provide expertise/strategic guidance to staff within the organization to execute the field monitoring strategy, and will work closely and collaboratively with other senior and functional leaders to ensure fully harmonized and integrated strategies and operations to drive successful portfolio planning and execution. Key responsibilities will include coordinating and leading the US field team, including CRAs, CRA Managers, and FSP personnel, in the areas of functional management, territory planning and preferred site relations, financial oversight, vendor management, strategic resource allocation in support of risk-based monitoring, and ensuring ICH/GCP compliance.

Your responsibilities include, but not limited to:
Field Monitoring strategy
• Drives Trial Monitoring Strategy to achieve Global and Regional/Local business objectives.
• Creates and implements. innovative practices and site engagement tactics to advance field planning, execution, patient engagement and quality in line with TMO strategies and objectives.
Allocation, initiation and conduct of trials.
• Ensures trial execution is according to enrollment commitment, timelines, and budget; tracks performance through key performance indicators; drives Regional re-allocation or corrective action when needed.
• Builds competitive advantages for global development trials within the Region considering medical standard of care, competitive environment, and local business drivers.
Delivery of quality data and compliance to quality standards
• Accountable for Field Monitoring quality and issue resolution through timely review, approval, resolution and/or escalation of KPIs.
Management of people and resources management
• Responsible for the hiring, training, development, and retention of a team of Field Monitoring staff to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Performs ongoing assessment and allocation of monitoring resources to ensure balanced staff workload.
• Responsible for managing and addressing staff performance targets per defined quality performance indicators.
Budget and productivity
• Manage Area budget and monitors, tracks, and approves staff travel and expense to ensure compliance to T&E policy

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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322123BR

Field Monitoring Head US Region, Trial Monitoring (Remote)

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