Clinical Study Data Lead - East Hanover

Novartis • East Hanover, NJ

5d • $119,700 - $222,300 • Hybrid

About The Position

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. 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.

Requirements

• Bachelor’s degree, or equivalent, in life sciences, computer science, or a related field.
• 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.

Nice To Haves

• Postgraduate qualification in a relevant field is beneficial.

Responsibilities

• 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.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior