Clinical Quality Assurance Manager

1 day ago

Madurai, Tamil Nadu, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000
Clinical Quality Assurance Specialist

We are seeking an experienced Clinical Quality Assurance Specialist to provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.

Key Responsibilities
  • Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations and trial oversight meetings, writing, reviewing, updating, and formatting standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  • Address QA-related questions from study teams in real time, providing clear and actionable guidance.
  • Support inspection readiness and contribute to continuous improvement of QA systems and processes.
Qualifications
  • Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • Experience: 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 Veeva QMS.
  • 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.
Contract Opportunity

This is a full-time contract role offering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

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