Senior Clinical Data Validation Expert

1 day ago


Tiruppur, Tamil Nadu, India beBeeClinicalDataSpecialist Full time ₹ 15,00,000 - ₹ 25,00,000
Job Description:

As a Clinical Data Specialist, you will play a vital role in ensuring the accuracy and integrity of clinical data.

  • Responsibilities:
  • Collaborate with cross-functional teams to design and implement data management strategies.

  • Develop and maintain standard operating procedures (SOPs) for data collection, validation, and reporting.

  • Perform user acceptance testing (UAT) for CRF screens, database edit checks, and exceptional reports/listings.

  • Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.

  • Conduct quality control (QC) on metadata listings and peer review of programming checks.

  • Ensure compliance with regulatory requirements and internal SOPs.

  • Document and share study-related testing deliverables and lessons learned.

Required Skills and Qualifications:

Education: Bachelor's degree in Life Sciences, Computer Science, or related field.

Experience: 8+ years of experience in clinical data testing and validation.

Technical Skills: Strong experience with clinical study setup and CDMS platforms, CTMS, Medidata Rave, Oracle InForm.

  • Key Technical Competencies:
  • Software Development Life Cycle (SDLC), validation methodology, and document management.

  • Clinical data standards, GxP/GcP compliance, and internal SOPs.

Benefits:

This role offers a unique opportunity to work with a highly skilled team, contribute to cutting-edge projects, and develop your skills in clinical data management.

Others:

As a Clinical Data Specialist, you will be part of a dynamic team that is passionate about delivering high-quality results. If you are looking for a challenging and rewarding career, apply now



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