Clinical Data Specialist

2 weeks ago

Agra, Uttar Pradesh, India beBeeClinicalData Full time ₹ 1,80,00,000 - ₹ 2,00,00,000

**Clinical Data Testing Expert Role**

We are seeking a highly experienced Clinical Data SME Tester to fill this position.

The ideal candidate will possess a strong background in clinical data testing and validation, with expertise in CDMS platforms and CTMS.

**Key Responsibilities:**

  • Education: Bachelor's degree in Life Sciences, Computer Science, or related field.
  • Experience: 8+ years of experience in clinical data testing and validation.
  • UAT Responsibilities: Perform UAT for CRF screens, database edit checks, and exceptional reports/listings.
  • Clinical Study Setup Configuration: Test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
  • Data Validation: Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.
  • Collaboration: Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
  • Technical Expertise: Strong experience with clinical study setup and CDMS platforms and CTMS.
  • Quality Control: Conduct QC on metadata listings and peer review of programming checks.
  • Automation: Support automation tool validation and standardization of test scripts.
  • Clinical Data Standards: Ensure consistent use of clinical data standards across programs and repositories.
  • Database Validation: Work with Clinical Data Management Systems (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
  • Compliance: Ensure compliance with GxP/GcP and internal SOPs.
  • Documentation: Document and share study-related testing deliverables and lessons learned.

**What We Offer**

A challenging role with opportunities for professional growth and development.

A collaborative work environment with experienced professionals.

Competitive compensation and benefits package.

Opportunities for advancement within the organization.

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