Senior Clinical Assurance Specialist

8 hours ago


Kollam, Kerala, India beBeeQuality Full time ₹ 80,00,000 - ₹ 1,20,00,000
Clinical Assurance Professional">Job Overview

We are seeking an experienced clinical assurance professional to provide day-to-day support in ensuring compliance with Good Clinical Practice (GCP) and quality oversight across ongoing clinical trials.

Key Responsibilities:
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
  • Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes within a quality management system, including document control, training, and corrective action process management.
  • Address QA-related questions from study teams in real time, providing clear and actionable guidance.
  • Support inspection readiness and contribute to the continuous improvement of QA systems and processes.
Qualifications
  • Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
  • Prior experience supporting clinical study teams in a QA capacity.
  • Hands-on experience with a quality management system.
  • Technical Skills: Proficient in MS Office (Excel, PowerPoint, Word). Skilled in technical writing, SOP drafting, and document formatting.
  • Soft Skills: Excellent communication and interpersonal skills. Strong organizational skills with the ability to work independently.


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