Clinical Systems Associate II
One DNA Way South San Francisco, CA 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- 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 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
- 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 IxRS, eCOA, Clinical Trial Management Systems, 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 MS Excel, Project, Word.
- Highly effective verbal & written communication skills
- Highly effective team player and interpersonal skills (globally, internally and externally) Strong customer focus
- Bachelor's degree
- 2-5 years experience in Biotech/Pharmaceutical/Healthcare industry with clinical trial experience.