Clinical Quality Assurance Specialist

20 hours ago

Mangalore, Karnataka, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,20,00,000

**Job Title:** Clinical Quality Assurance Specialist

We are seeking an experienced Clinical Quality Assurance Specialist to provide day-to-day 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.
  • Write, review, update, and format 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.
  • Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

**Required Skills and 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 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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