SMA
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Study Management Associate (SMA)
Job Purpose
- The Study Management Associate (SMA) is a key member of the Global Study Team, contributing to the successful delivery of clinical studies within agreed timelines, budget, and quality standards while ensuring inspection readiness through oversight of study eTMF completeness.
- The SMA role is designed to drive operational excellence by supporting continuous improvement initiatives, sharing best practices, and enhancing study delivery efficiency across the organization.
Key Responsibilities
- The SMA works in close partnership with the Study Manager (SM) and/or Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study start-up through study archival,
with a focus on setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans (CSAP).
- Works cross-functionally with internal teams and external partners on clinical study management activities, as agreed with the Study Delivery Lead, for both in-house and outsourced studies across all phases and therapeutic areas, in accordance with STOM, applicable clinical trial regulations, and ICON procedures, policies, best practices, and standards.
- Provides subject matter expertise across key study management processes and systems throughout the study lifecycle.
- Monitors study conduct and progress, proactively identifying, resolving, and escalating risks or issues that could impact study quality, timelines, or budget.
- Reviews key clinical documents, including Protocols and Informed Consent Forms, and supports the development of study plans such as:
- Monitori
📌 Sma I/Ii (Bengaluru)
🏢 IRE
📍 Bengaluru