clinical trial operations, Clinical trials data systems testing/UAT *** Direct end client ***

Acceptance testing, Biotechnology, Clinical trial management system, Clinical trials, Defect tracking, GxP, Health care, Information systems, Issue resolution, Pharmaceutics, QA, IxRS, eCOA, eConsent, Clinical Trial Management Systems (CTMS), Clinical Supply Systems, SQL, KPI, Test cases, clinical trial operations
Contract W2, Contract Independent, Contract Corp-To-Corp, 12 Months
Depends on Experience

Job Description

Primary Responsibilities & Accountabilities
• Supports the Clinical Systems Leader and Sys Ops Manager to efficiently deliver effective clinical trial
solutions and systems, including set-up and coordination of system startup, UAT, maintenance,
enhancements, close down activities and any associated meetings
• Partners with Clinical Systems Leader, Sys Ops Manager, Protocol Execution Teams (PET) and other
stakeholders to generate test case scenarios specific to customized system design
• Manages and executes UAT process for various systems, including defect management and resolution
• Collaborates with IT Operational Team to resolve end user requests and issues ensuring prompt
resolution of system issues and provides timeline and accurate responses to end users and other
• Identifies business needs / issues and provides technical solutions to address them
• Gathers, receives and interprets data to provide input on continuous improvement opportunities
• Monitors key performance indicators and conducts analysis to identify root causes for defects and
recommend process improvements
• Provides timely, quality study metrics to study teams using a variety of tracking tools Experience, Skills, Knowledge
• Ability to partner with vendor resources and other stakeholders to ensure understanding of data and
• Facilitate issue resolution in a timely fashion, removing roadblocks for project team to meet project
• Knowledgeable with processes and principles of project management
• Knowledgeable with User Acceptance Testing (UAT) methodologies
• Knowledgeable with Clinical Operations and Information Systems such as IxRS, eCOA, eConsent, Clinical Trial Management Systems (CTMS), and Clinical Supply Systems
• Proficient problem solving skills as related to software systems
• Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug
development experience
• Comfortable working in a fast-paced, dynamic environment
• Highly proficient in word processing, project tracking, and spreadsheet software such as Google Suite, MS Excel, Project, Word.
• Highly effective verbal & written communication skills
• Highly effective team player and interpersonal skills (globally, internally and externally)
• Strong customer focus Education/Qualifications
• Bachelor’s degree
• 2-5 years experience in Biotech/Pharmaceutical/Healthcare industry with clinical trial experience

Dice Id : 10126850
Position Id : CLINUAT
Originally Posted : 1 month ago
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