Senior Clinical Data Specialist

1 day ago

Bengaluru, Karnataka, India beBeeMedical Full time ₹ 1,20,00,000 - ₹ 1,50,00,000

Job Overview

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The Centralized Monitoring Unit is a department within Clinical Drug Development that brings together skilled medical professionals and technical programmers to ensure patient safety and wellbeing of all clinical trial participants.

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As a Senior Medical Reviewer, you will be responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures high quality and consistency of medical data, with emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs).

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Your key responsibilities include collaborating closely with study team members, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. You will also contribute to or participate in trial planning activities related to medical review, perform quality check measures, clarify and resolve issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.

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You will present findings of Medical Review to relevant Medical Specialists to enable decision-making, document medical reviews in the sponsor TMF, and ensure close collaboration with relevant study group members. Additionally, you will provide training on the project and process to new team members, review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review.

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For success in this role, you should have a graduate degree in Medicine or a related field, preferably 3-5 years of relevant experience in Clinical Drug Development, and 1-2 years of project management experience. You should have a solid understanding of ICH guidelines and GCP principles, proficiency in computer applications, and a strong grasp of medical terminology and clinical trial processes.

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Required Skills and Qualifications

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  • Graduate degree in Medicine or a related field">
  • 3-5 years of relevant experience in Clinical Drug Development">
  • 1-2 years of project management experience">
  • Solid understanding of ICH guidelines and GCP principles">
  • Proficiency in computer applications">
  • Strong grasp of medical terminology and clinical trial processes">
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Benefits

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This role offers opportunities for professional growth and development in a dynamic and collaborative environment.

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Others

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Please note that we are looking for candidates with strong communication and interpersonal skills, ability to work in a fast-paced environment, and a passion for delivering high-quality results.

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