Clinical Study Data Lead - East Hanover

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.

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 deliverytypically 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.

• 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.

• 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.

• Bachelors 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…