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Clinical Data Manager in San Diego, CA at Vaco

Date Posted: 12/5/2018

Job Snapshot

Job Description

Data Management operational support of sample collection, clinical validation and reproducibility studies at Illumina Work within standardized DM processes, SOPs and documentation templates to generate key project DM deliverables (Data Management Plans, Data Transfer Plans, Database Specifications, etc.) Work with Electronic Data Capture tools and vendors and assist with development, design and testing of project Case Report Forms, DM workflows Develop in house data processing software, database loading, processing and reporting tables as well as design and execute software test cases for software validation exercises Effectively communicate and manage expectations with project teams and EDC tool vendors and handle timely change requests as needed

Skills: Skills and Qualifications:

Bachelor's degree or above (Master's preferred) in a biomedical or computer science discipline Proficient in computer skills for communication and reporting (word processing, spreadsheets, presentations and flowcharts) Proficient in computer programming skills (Python, MS Visual Studio, other...) and database development environments (MySQL, SQL Server, other...) Strong communication and partnership skills with clinical site personnel, Clinical Research Associates, Biostatistics and external tool vendors Strong knowledge of medical and data management terminology Experienced and understands the practice of Software Development Life Cycle (SDLC) particularly in the validation and verification of software Experienced and understands the practice of Clinical Data essentials for trial management including CRF design and completion guidelines and development of processes and audit trails for handling data transfers

Experience:

At least 3 years of experience in data management in a clinical research environment. Experience in a lead role preferred At least 2 years of experience in software projects in a development role

Skills and Experience:

Required Skills:

  • AUDIT
  • CLINICAL RESEARCH
  • CRF
  • CRF DESIGN
  • DATA MANAGEMENT
  • Additional Skills:
  • LIFE CYCLE
  • SDLC
  • SOFTWARE DEVELOPMENT
  • SOFTWARE DEVELOPMENT LIFE CYCLE
  • TRIAL MANAGEMENT
  • .NET
  • BIOMEDICAL
  • BIOSTATISTICS
  • CASE REPORT
  • CASE REPORT FORMS
  • COLLECTION
  • COMPUTER PROGRAMMING
  • CONDITIONAL RANDOM FIELD
  • DATA COLLECTION
  • DATABASE
  • DATABASE DEVELOPMENT
  • DATABASES
  • DOCUMENTATION
  • MICROSOFT WORD
  • MS SQL SERVER
  • MS VISUAL STUDIO
  • MYSQL
  • OPERATIONAL SUPPORT
  • OPERATIONS
  • PYTHON
  • SOFTWARE VALIDATION
  • SOPS
  • SQL
  • SQL SERVER
  • STRUCTURED SOFTWARE
  • TEST CASES
  • VISUAL STUDIO
  • WEB DATABASE
  • WORD