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Senior Analyst, EDC Database Validation

Company: Planet Pharma
Location: Irvine
Posted on: June 8, 2021

Job Description:


Develop test scripts to ensure accuracy of data structure

Key Responsibilities:

  • Develop test scripts, review tests scripts with data managers, prepare test plan and reports for database validation and/or user acceptance testing to ensure accuracy of database structure and appropriate data is collected with proper validation
  • Provide insights, identify validation issues and partner with stakeholders (e.g., programmers, data managers, and data coordinators) to address and resolve issues
  • Create validation summaries and reports and provide insights into the validation to ensure project deliverables and timelines are met in collaboration with Internal team, Data Management, Programmers, Clinical Affairs
  • Create and update functional specifications for the validation tool (e.g., SAS program) using specialized technical knowledge
  • Author and execute validation scripts for clinical reports
  • Perform study database design and build programming activities
  • Assist in creating clinical listings and reports for data managers
  • Other incidental duties

Additional Skills:

  • Proven expertise in Microsoft Office Suite
  • Basic project management skills
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
  • Excellent problem-solving and critical thinking skills
  • Full knowledge and understanding of policies, procedures and guidelines relevant to EDC (Electronic Data Capture) validation
  • Full knowledge of processes and procedures in clinical data management
  • Full knowledge of relational databases, systems, and programming languages
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Strict attention to detail
  • Ability to manage competing priorities in a fast paced environment
  • Adhere to department SOPs and a regulated environment

Education and Experience:

Bachelor's Degree in (e.g., computer science, or any field related to clinical research, data management, software programming) Required 4 years years experience programming or validation experience Required Experience with EDC (Electronic Data Capture) systems required (e.g., Medidata RAVE) Required Programming experience in the pharmaceutical/medical device industry setting Preferred

Keywords: Planet Pharma, Irvine , Senior Analyst, EDC Database Validation, Other , Irvine, California

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