Senior Clinical Data Validation Specialist

4 days ago

Jodhpur, Rajasthan, India beBeeClinicalDataExpert Full time ₹ 18,00,000 - ₹ 27,00,000
Clinical Data Expert

Overview:

  • This role focuses on the validation and testing of clinical data management systems to ensure accuracy and compliance with regulatory standards.

About the Role:

  • We are seeking a skilled Clinical Data SME Tester to join our team. As a Clinical Data SME Tester, you will be responsible for performing User Acceptance Testing (UAT) for Clinical Research Form (CRF) screens, database edit checks, and exception reports/listings.
  • You will also test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
  • Your expertise in clinical data testing and validation will be invaluable in ensuring the quality and integrity of our clinical data.

About You:

  • Bachelor's degree in Life Sciences, Computer Science, or related field.
  • 8+ years of experience in clinical data testing and validation.
  • Proficiency in using CDMS platforms and CTMS.
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration skills.

Requirements:

  • Extensive knowledge of clinical trial protocols and processes.
  • Experience with GxP/GcP and internal SOPs.
  • Document management skills.

Benefits:

  • This is an excellent opportunity to work with a talented team and contribute to the success of our organization.
  • Our company offers a dynamic and supportive work environment.

Others:

  • Solid understanding of SDLC, validation methodology.
  • Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
  • Support automation tool validation and standardization of test scripts.
  • Ensure consistent use of clinical data standards across programs and repositories.
  • Work with Clinical Data Management Systems (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
  • Document and share study-related testing deliverables and lessons learned.

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