Job Description

Job Description Summary

#LI-Hybrid

This position is based out of our offices in East Hanover, New Jersey, with a Hybrid working expectation of 12 days a month onsite.

Novartis cannot sponsor Visas for this location.

Are you energized by the opportunity to shape clinical data strategy across complex trials and help deliver high-quality, submission-ready data that supports faster, better decisions for patients? As a Clinical Study Data Lead within Clinical Data Operations, Global Clinical Operations, you will serve as a trusted data strategy partner to Clinical Trial Teams and cross-functional stakeholders, bringing clarity, consistency, and accountability to end-to-end clinical data delivery across multiple trials.

Job Description

Who Will Thrive in This Role

This opportunity is well suited for an experienced clinical data management professional with strong operational leadership, sound judgment under pressure, and the ability to influence cross-functional teams. The ideal candidate brings deep understanding of clinical trial methodology, Good Clinical Practice, data standards, regulatory expectations, and hands-on trial-level data delivery—typically gained through proven experience in clinical data management within a regulated R&D environment.

If you are ready to bring strategic data leadership, operational discipline, and a quality-first mindset to complex clinical trials, this role offers the opportunity to make a meaningful contribution to predictable delivery, inspection readiness, and high-quality clinical data outcomes across the portfolio.

What You’ll Contribute

• Lead clinical data management activities across multiple assigned trials, ensuring high-quality, timely, and compliant data outputs.
• Define and drive trial-level data strategies aligned with program objectives, data standards, and regulatory expectations.
• Oversee end-to-end data management from data collection and database design through data cleaning, review, and database lock readiness.
• Represent Clinical Data Management in Clinical Trial Team and Data Quality Team forums, influencing decisions and resolving data topics with clarity and urgency.
• Identify and manage data risks, dependencies, and cross-trial issues through proactive mitigation, root cause analysis, and timely escalation where needed.
• Reinforce Quality by Design, audit readiness, and consistent application of standards and processes across assigned trials.
• Share insights, lessons learned, and practical guidance to strengthen decision-making and continuous improvement across the trial portfolio.

What Differentiates This Role

• Single point of accountability: You will own end-to-end clinical data strategy and delivery across multiple trials, creating consistency and predictability across the portfolio.
• Strategic influence with hands-on impact: The role combines operational execution with data-driven decision-making in governance forums where clinical data topics are shaped and resolved.
• Cross-functional leadership without direct reports: You will coordinate resources, influence stakeholders, and guide Principal Study Data Leads through expertise, partnership, and credibility.
• Direct contribution from protocol development to submissions: Your work supports data specific inputs to the protocol, set up of high-quality dataflows, smooth database locks and timely Health Authority submissions, making the role critical to program delivery and patient impact.
• Inspection-ready mindset: The position places strong emphasis on quality, compliance, standards, proactive risk management, and regulatory expectations.

Essential Requirements

• Bachelor’s degree, or equivalent, in life sciences, computer science, or a related field. Postgraduate qualification in a relevant field is beneficial.
• Proven experience managing clinical trial data and driving clinical data strategy and execution across multiple studies and delivering to deadlines.
• Ideally a minimum of 5-8 years' experience in clinical data management.
• Strong knowledge of clinical trial methodology, good clinical practice (GCP), and medical terminology.
• Advanced ability to analyze and interpret data and apply critical thinking, and make data driven decisions.
• Demonstrated leadership and collaboration skills in cross-functional, global team environments.
• Ability to identify risks, solve complex problems, and implement effective data management solutions.
• Excellent communication skills, with ability to influence stakeholders across functions and organizations.
• Experience mentoring colleagues and sharing knowledge to support team and project success.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $119,700.00 - $222,300.00 Annual

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days,

holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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.

Accessibility and 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 us.reasonableaccommodations@novartis.com 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.

Salary Range

$119,700.00 - $222,300.00

Skills Desired

Clinical Data, Clinical Data Analysis, Clinical Data Management, Clinical Data Standards, Clinical Research Trials, Clinical Studies, Clinical Trials, Data Architecture Development, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Good Clinical Data Management Practice (GCDMP), Master Data, Waterfall Model