REQ-10038738
2月 05, 2025
USA

摘要

#LI-Hybrid
Welcome to the new and exciting Central Monitoring Head role - we are open for applications! The incumbent will be a: visionary, strategic leader and thrive in driving functional excellence in clinical trial monitoring. The new 2025 regulations means that you will be building-up and overseeing state-of-the-art Central Monitoring capabilities while advancing field monitoring. This opportunity is about building new processes, growing a team, solidifying relationships in a global matrix environment, overseeing data trends and incorporating new technologies. Therefore, to be a successful applicant you will need to have excellent communication skills, embrace innovation, collaborative, agile, empathetic, empower, manage resistance, and have a superior clinical trial knowledge with a thorough understanding of field monitoring landscape.

About the Role

Key Responsibilities:

Strategy & Execution:

  • Establish and implement a Clinical Monitoring function at Novartis, including processes, tools, and governance frameworks.
  • Define and execute Clinical Monitoring strategies, leveraging data analytics and centralized oversight.
  • Develop and optimize Clinical Monitoring resourcing strategy, including hiring, onboarding, development, and retention of Clinical Monitoring Team, and perform resource management in line with Development
  • Establish and actively monitor objectives in line with GCO priorities, key metrics/KPIs and industry benchmarks.
  • Update senior leadership on CM monitoring performance, challenges, and opportunities for improvement.
  • In the long-term, ensure CM function evolves and adjusts to a remain a value-added function and to ensure compliance with latest regulations.

Collaboration with Stakeholders:

  • Coordinate cross-functional interactions between monitoring teams and key stakeholders within Development in areas such as CDO (especially with Data Analyst team to support CM’s technologies), process and compliance, quality assurance, and regulatory affairs.
  • Act as a key connector between CM, global Risk Surveillance team, and field monitoring functions.
  • Partner with SSO Hub Heads to integrate central monitoring into existing monitoring ecosystem and adjust central and field monitoring roles accordingly.

Leadership and Change Management:

  • Guide the organization through the transition to a CM model, driving cultural and operational change to achieve buy-in and sustained success.
  • Act as a champion for CM innovation, identifying opportunities for advancements and staying ahead of industry trends.
  • Break down silos through an enterprise mindset. Focus on delivery through collaboration and bringing people together to work towards the same purpose across the organization.

Essential Requirements:

  • University degree in life science, business or operations. An Advanced degree is preferred.
  • ≥ 10 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs. Strong clinical and budgeting/finance experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials. Specific central monitoring / monitoring experience preferred.
  • ≥ 6 years of recent experience in people management and/or team leadership. Strong leadership and people management skills in global setting and proven ability to develop high performing teams and diverse profiles including manager of manager experience
  • Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.
  • Strong capability in working in a Global/Country matrixed environment. Organizational awareness, including significant experience working cross functionally.
  • Proven track record in study operations process set-up and/or improvement(s).
  • Strong technical, analytical and quantitative problem-solving skills.
  • Ability to articulate the bigger picture to foster confidence and trust.

The pay range for this position at commencement of employment is expected to be between $176,400 and $327,600 /year; however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical locations, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: 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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Development
Innovative Medicines
USA
New Jersey
East Hanover
Research & Development
Full time
Regular
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10038738

Central Monitoring Head

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