Novartis

Actively Hiring

Clinical Study Manager

East Hanover, United States

Full time

Role Overview

Accountable, with per needed-basis oversight from the Study Director-community Lead (SD-CL), for the execution and delivery of the GCO supported clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol.

About Novartis

Novartis is a global healthcare company that uses innovative science and technology to address some of society's most challenging healthcare issues.

Key Responsibilities

Co-leads the clinical trial team with the CSL with per needed-basis oversight from the Study Director-community Lead
Acts as the CTT product owner with duties and responsibilities for delivery of operational strategy
Guides planning and decision making at the study level and delivers assigned clinical study/studies
Proactive risk management and inspection readiness
Responsible for developing clinical study timelines and overseeing assigned study budgets
Ensures systems are maintained with up-to-date study status, risks, and issues

Requirements & Eligibility

Bachelor's degree in life sciences/healthcare (or clinically relevant degree)
4+ years of recent involvement in clinical research or drug development in an academic or industry environment
3+ years of recent contribution to and accomplishment in all aspects of conducting clinical studies in a global/matrix environment
Expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), and local/National Health Authorities regulations
Strong project management skills and demonstrated ability to meet timelines

Required Skills & Tech

Clinical ResearchDrug DevelopmentGCP/ICHProject ManagementRisk Management