Clinical Data Operations Specialist

18 hours ago

Bikaner, Rajasthan, India beBeeClinicalDataOperations Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Clinical Data Operations Specialist

We are seeking an experienced Clinical Data Operations Specialist to join our team.

Key Responsibilities:
  • Bachelor's Degree and 8+ Years of Experience
  • Clinical Study Setup and Data Validation
  • Collaboration with Clinical Data Scientists and Study Data Managers
  • Strong Experience with CDMS Platforms and CTMS
  • Edit Check Specifications, UAT Scripts, and QC on Metadata Listings
  • Automation Tool Validation and Standardization of Test Scripts
  • Clinical Data Standards Across Programs and Repositories
  • Database Builds and Data Flows in Medidata Rave and Oracle InForm
  • Compliance with GxP/GcP and Internal SOPs
  • Documenting and Sharing Testing Deliverables and Lessons Learned

A Clinical Data Operations Specialist plays a crucial role in ensuring the accuracy and quality of clinical data. They perform various tasks such as testing clinical study setup configurations, validating external data acquisition, and collaborating with Clinical Data Scientists and Study Data Managers. The ideal candidate should have strong experience with clinical study setup and CDMS platforms, as well as a solid understanding of SDLC, validation methodology, and document management.

Required Skills and Qualifications:
  • Bachelor's degree in Life Sciences, Computer Science, or related field
  • 8+ years of experience in clinical data testing and validation
  • Strong experience with clinical study setup and CDMS platforms
  • Solid understanding of SDLC, validation methodology, and document management

The Clinical Data Operations Specialist will work closely with Clinical Data Scientists and Study Data Managers to understand study scope and expectations. They will be responsible for performing UAT for CRF screens, database edit checks, and exceptional reports/listings. Additionally, they will test clinical study setup configurations, including protocol parameters, visit schedules, and form designs.

Benefits:
  • Opportunity to Work with Experienced Team Members
  • Chance to Develop Skills in Clinical Data Operations
  • Contribution to Ensuring Accuracy and Quality of Clinical Data

If you are passionate about clinical data operations and have the required skills and qualifications, we encourage you to apply for this exciting opportunity.

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