Accountability, Biotechnology, Customer focus, Clinical trials, Computerized system validation, Pharmaceutics, Relationship building, Process modeling, Business analysis, Reporting, Good Clinical Practice
Contract W2, Contract Independent, Contract Corp-To-Corp, 12 Months
Depends on Experience
Travel not required

Job Description

  • Total work experience of around 10 years plus
  • 5-7 years of experience as an IT business systems analyst and a demonstrated ability to work in a fast-paced, high-growth environment.
  • Experience and understanding of application development methodology - including Agile and Waterfall approaches, functional requirements, process modeling, and re-engineering, use case development, user acceptance testing, organizational change management, and large-scale system implementations.
  • Good to have experience working on data at scale (high-dimensionality datasets with longitudinal clinical trial data, real-world data, and digital health
  • Manage compliance documentation processes and systems for Client and business partners
  • Be accountable for documentation, which may include, but is not limited to: System Risk Assessments, Data Classification Reports, User Requirements, Validation Plans, Validation Reports, Validation Registries, Requirements Traceability Matrices, Test Plans, Test Reports
  • Strong Functional and/or technical specifications
  • Excellent written and verbal communication skills; able to quickly produce written, well-organized documentation; excellent presentation and meeting facilitation skills.
  • Proven skills in relationship building, customer-focus, decision-making, and problem-solving.
  • Pharmaceutical/Biotech Good Clinical Practice (Google Cloud Platform) environment
  • Other Computer System Validation documents and related systems

PST work timings


if interested, please email your updated resume along with current location and the visa status.




mshah at qualityitsource dot com

Dice Id : 10122314
Position Id : BIOTECHDA
Originally Posted : 5 months ago
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