Clinical Validation Specialist

7 days ago

Hyderabad, Telangana, India beBeeBusinessSystemsAnalyst Full time ₹ 15,00,000 - ₹ 25,00,000
Key Responsibilities of a Business Systems Analyst in Clinical Operations

This position entails developing and managing test cases, protocols, and validation documentations within the Veeva Validation Manager Vault.

  1. Develop and manage test cases, protocols, and validation documentations within the Veeva Validation Manager Vault.
  2. Provide experienced technical support in validation to meet objectives of quality, output, and cost in developing, troubleshooting, standardizing, and improving new and existing validation methods/procedures.
  3. Prepare, implement, document, and report validation protocols in line with GxP and other regulatory requirements and standards.
  4. Ensure that all validation test procedures are in line with current technology, corporate, and governmental regulations.
  5. Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate.
  6. Implement test scripts to ensure system compliance with regulatory requirements and organizational standards.
  7. Identify, document, and track defects during the testing process.
  8. Collaborate with development teams to resolve defects and validate fixes.
  9. Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
  10. Maintain comprehensive audit trails and validation documentations to support regulatory inspections.
  11. Configure and optimize workflows within the Validation Manager Testing Vault to streamline test management and approval processes.
  12. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements.
  13. Act as a liaison between technical teams and customers to ensure system requirements are met.
  14. Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes.
  15. Offer ongoing support to ensure effective use of the platform.
  16. Generate reports and dashboards to monitor testing progress, defect trends, and validation status.
Requirements for this Position:Basic Qualifications:
  • A Master's degree or equivalent experience in Computer Science, Business, Engineering, IT, or a related field.
  • 6-8 years of Global Pharmaceutical industry experience.
  • Solid understanding of pharmaceutical clinical operation and data management business processes.
  • Experienced in pharmaceutical regulations and specifications.
  • Expertise in defining and implementing validation strategies aligned with regulatory requirements.
  • Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
  • Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.
  • Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager, Vault, etc.
Preferred Qualifications:
  • Proficiency in automation tools and validation software.
  • Experience with DevOps, Continuous Integration, and Continuous Delivery methodologies.
  • Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile, etc.).
Professional Certifications:
  • Veeva Vault Platform Administrator (mandatory).
  • SAFe DevOps Practitioner (preferred).
  • SAFe for teams (preferred).
Soft Skills:
  • Able to work under minimal supervision.
  • Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
  • Excellent analytical and gap/fit assessment skills.
  • Strong verbal and written communication skills.
  • Ability to work effectively with global, virtual teams.
  • High degree of initiative and self-motivation.
  • Ability to manage multiple priorities successfully.
  • Team-oriented, with a focus on achieving team goals.
  • Strong presentation and public speaking skills.

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