Lead Analytical Monitor

ICON plc

6 - 11 years

7 - 11 Lacs

chennai bengaluru thiruvananthapuram

Posted:1 day ago| Platform:

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Skills Required

data analysis assurance operational excellence gcp analytical clinical trials healthcare clinical research manager quality control continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are currently seeking a Central Review Lead to join our diverse and dynamic team. As a Central Review Lead at ICON, you will play a pivotal role in overseeing and coordinating centralized review activities for clinical trials, contributing to the advancement of inNvative treatments and therapies.

What you will be doing

Lead and oversee the planning, execution, and monitoring of centralized review activities, including imaging assessments, laboratory analyses, and other centralized evaluations.

Collaborate closely with study teams, clinical sites, and external vendors to ensure the timely and accurate collection, transfer, and interpretation of clinical trial data.

Develop and implement standardized processes, protocols, and quality control measures to optimize the efficiency, accuracy, and reliability of centralized review operations.

Provide leadership and guidance to central review teams, ensuring adherence to protocol requirements, regulatory standards, and best practices.

Proactively identify and address issues, deviations, and risks related to central review activities, driving continuous improvement and operational excellence.

Your profile

Education: Bachelor s in health/data sciences/ Masters degree in health/data sciences
Experience: 6+ years, trial site operations knowledge
Skills: Data analysis, familiarity with ICH-GCP, RBQM/RBM/QbD concepts, statistical/data visualization (Advanced).
Strong leadership and project management skills with a track record of successfully leading cross-functional teams and managing complex projects.
In-depth knowledge of central review methodologies, technologies, and regulatory requirements (e.g., ICH GCP, FDA regulations).
Excellent communication, interpersonal, and problem-solving abilities, with the ability to effectively collaborate and communicate with stakeholders at all levels.

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