Senior Clinical Data Specialist

2 days ago

Mumbai, Maharashtra, India beBeeClinicalData Full time ₹ 12,00,000 - ₹ 15,40,000

Job Description:

We are seeking a seasoned Clinical Data Specialist to join our team. In this role, you will be responsible for ensuring the accuracy and integrity of clinical data across various programs and repositories.

Key Responsibilities:

  • Bachelor's degree in Life Sciences or Computer Science.
  • 8+ years of experience in clinical data testing and validation.
  • Perform User Acceptance Testing (UAT) for CRF screens, database edit checks, and reports/listings.
  • Test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
  • Validate external data acquisition and ensure accurate processing.
  • Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
  • Strong experience with clinical study setup and CDMS platforms.
  • Review edit check specifications; write and execute UAT scripts.
  • Conduct Quality Control (QC) on metadata listings and peer review of programming checks.
  • 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.
  • Ensure compliance with GxP/GcP and internal Standard Operating Procedures (SOPs).
  • Document and share study-related testing deliverables and lessons learned.

Required Skills and Qualifications:

  • Solid understanding of Software Development Lifecycle (SDLC), validation methodology, and document management.
  • Excellent analytical and problem-solving skills.
  • Ability to collaborate effectively with cross-functional teams and communicate complex technical information to non-technical stakeholders.
  • Strong background in clinical data testing and validation.

Benefits:

This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization.

Others:

If you are a motivated and detail-oriented individual with a passion for clinical data, we encourage you to apply.

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