Clinical Programmer II

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Job Title: Clinical Programmer II

Job Location: LOCATION

Job Overview

The Clinical Programmer II (CP-II) supports clinical programming services. The CP-II creates, deploys, and maintains clinical databases and provides support to the study team as needed. The CP-II provides technical and functional expertise in EDC and IRT systems, and where appropriate, mentors and supports other staff and peers on clinical databases.

Job Duties And Responsibilities

• Design, manage, and maintain the clinical databases in keeping with the protocols and amendments, standard operating procedures (SOPs), good clinical practices (GCP), and other regulatory requirements.
• Review system specifications and Data Validation Plan (DVP) and perform programming and configuration activities for assigned projects
• Participate in release to production activities
• Deliver milestones in a timely fashion for assigned projects
• Communicate progress on milestones to management and other stakeholders
• Review study risks and mitigation plans related to clinical databases and provide inputs to management and study teams
• Serve as the subject matter expert on data collection strategy and system functionality
• Provide ongoing technical support to end-users in assigned projects
• Participate in process improvements and the implementation of new systems and tools, as applicable
• Effectively present to groups and conduct or participate in meetings, as applicable
• Support less experienced Clinical Programmers
• Perform other tasks that are related to clinical programming, data analysis and reporting as assigned
  

Supervisory Responsibilities: No supervisory responsibilities

Job Requirements

• Education
  • Scientific, Informatics, Mathematics or Medical Documentation degree
• Experience
  • At least 2 years of experience in design and deployment of clinical databases
  • C#, SQL, and/or custom function programming (preferred)
  • Medidata and/or Medrio configuration (preferred)
  • Knowledge of pharmaceutical industry and data standards (preferred)
  • Regular use of MS-Office, revision control system (e.g. Subversion), and issue tracking software (e.g. JIRA)
• Skills/Competencies
  • Analysis: gathers and synthesizes complex information and requirements.
  • Problem solving: identifies and/or resolves problems in a timely manner.
  • Communication: speaks clearly and persuasively in positive or negative situations; good command of the English language
  • Time management: prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality management: promotes quality improvements and demonstrates accuracy and thoroughness.
  • Judgment: exhibits sound judgment and makes timely decisions.
  • Safety and security: actively promotes and personally observes safety and security procedures, and uses equipment and materials properly.
• Capabilities
  • Ability to work remotely as applicable
  • High level of working time flexibility to adjust to project flows
    
  The company will not accept unsolicited resumes from third party vendors.