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Clinical Systems Associate

Clinical Systems Associate
CA, South San Francisco

Job Description

Description:

gRED ECDi 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 ECDi and Clinical Operations. A successful CSA assists with the development, documentation and communication of UAT processes 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 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 IxRS, eCOA, eConsent, 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 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.

Skills:

Required

                  CLINICAL SYSTEMS

                  DRUG DEVELOPMENT

                  EXCEL

                  GXP

                  MAINTENANCE

Additional

MS EXCELPROJECT MANAGEMENTTEST CASEUATWORDACCEPTANCE TESTINGBIOTECH/PHARMACEUTICALCLINICAL OPERATIONSCLINICAL TRIALCLINICAL TRIALSDOCUMENTATIONHEALTHCARE INDUSTRYMETRICSMICROSOFT EXCELMICROSOFT WORDOPERATIONSPROBLEM SOLVINGPROCESS IMPROVEMENTSTEAM PLAYERTRIAL MANAGEMENTUSER ACCEPTANCEUSER ACCEPTANCE TESTING

Minimum Degree Required:        Associate's Degree (Community College, MBO)

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