Clinical Trial QA Specialist

7 days ago

Malappuram, Kerala, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000

Job Overview:

We are seeking a Quality Assurance Professional to provide day-to-day clinical quality assurance support across ongoing clinical trials.

  • The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.
  • Assure compliance with Good Clinical Practice (GCP) and internal quality standards.
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and trial oversight meetings.
  • Develop and maintain 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.
  • Collaborate with cross-functional stakeholders to align on quality expectations and risk mitigation.

Required Skills & Qualifications:

  • Bachelor's degree in life sciences, healthcare, or related discipline.
  • 5+ years of Clinical Quality Assurance experience.
  • 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.

Benefits:

As a Quality Assurance Professional, you will have the opportunity to work in a fast-paced, dynamic environment and contribute to the success of our clinical trials.

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