Field Monitoring Lead, Trial Monitoring (Remote)

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 Lead, Trial Monitoring, will lead the execution of field strategies within their geographic Area, and will work closely and collaboratively with other senior and functional leaders to drive successful portfolio planning and execution. Key responsibilities will include coordinating and leading the US Area field team of CRAs, CRA Managers, and FSP personnel, in the areas of functional management, territory planning and preferred site relations, risk-based monitoring implementation, and ensuring ICH/GCP compliance.

Your responsibilities include, but not limited to:
• Creates and implements field tactics to advance field planning, execution, patient engagement and quality in line with TMO strategies and objectives.
• Drives trial execution according to enrollment commitments, timelines, and budget; tracks performance through key performance indicators; drives Area re-allocation or corrective action when needed.
• Is strategically and operationally involved in allocating TMO field resources in collaboration with the US Field Monitoring Head.
• Is responsible for execution of annual Field Monitor Accompanied Visit Plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies in collaboration with Monitoring Excellence.
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
*Two open positions

EEO Statement
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

What you’ll bring to the role:
• Bachelors degree is required. Scientific or health discipline and advanced degree preferable
• At least 10 years of clinical study management experience in increasingly responsible leadership roles
• A minimum of 5 years managing direct reports
• Strong experience in vendor management, leading internal and contracted resources, site monitoring and clinical quality compliance, and managing clinical trial budgets and clinical finance activities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent team leadership skills capabilities with demonstrated capability to problem solve and mediate complex compliance issues and takes personal responsibility for outcomes
• 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.
• Fluent in both written and spoken English

** This position can be based remotely anywhere in the U.S. (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result.

*** The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This is a field leadership role with an expectation of 25% travel.

WHY CONSIDER NOVARTIS?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.Novartis.com/network

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