gRED Clinical Systems Associate
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gRED Clinical Systems Associate
Ref No.: 17-00162
Location: South San Francisco, California
Position Type:Contract
Start Date / End Date: 01/12/2017 to 12/12/2017
gRED Clinical Systems Associate
Job Purpose
The Clinical Systems Associate (CSA) provides the ongoing day-to-day maintenance of the clinical systems that support the business needs of the gRED Clinical Operations Study teams. A successful CSA assists with the development, documentation and communication of UAT process and procedures. The key deliverable for this role is to ensure timely, quality conduct of clinical systems according to protocols, standard operating procedures and all applicable regulations governing the conduct of clinical trials.
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 clinical systems, including defect management and resolution
Collaborates with gRED IT Operational Team to resolve end user requests and issues and ensures ensuring prompt resolution of system issues and provides timeline and accurate responses to end users and other stakeholders
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
Reports to the gRED Clinical Operations Sys Ops Manager
Experience, Skills, Knowledge
Ability to partner with vendor resources and other stakeholders to ensure understanding of data and requirements
Facilitate issue resolution in a timely fashion, removing roadblocks for project team to meet project objectives
Knowledgeable with processes and principles of project management
Knowledgeable with User Acceptance Testing (UAT) methodologies
Knowledgeable with Clinical Operations and Information Systems such as EDC, IxRS, Crystal, FELIx, 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 Microsoft Excel, Microsoft Project and Microsoft 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
3+ years' experience in Biotech/Pharmaceutical industry with clinical trial experience