Senior Clinical Programmer (Medidata Rave EDC Developer) - Remote, US

Published date Posted on Indeed on Jul 21, 2021

The specific job duties of a Senior Clinical Programmer may include but are not limited to:

  • Design, manage, and maintain the clinical study database 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
  • Develop and implement validation procedures for clinical studies and their appropriate tests and documentation.
  • Generate listings for manual data review
  • Contributing to the Data Management Plan (DMP)
  • Communicate progress on programming milestones to management and other stakeholders
  • Identify and communicate problems and propose solutions regarding possible data quality issues
  • Deliver milestones in a timely fashion for assigned projects
  • Provide input to protocol writing and forms design process
  • Provide input to contract department
  • Coordinate clinical programming resources and activities together with group heads
  • Coordinate the activities of other Clinical Programmers providing support as necessary
  • Support less experienced Clinical Programmers
  • Identify process, standards, or system enhancements and contribute to their continuous improvement
  • Perform other tasks that are related to clinical programming, data analysis and reporting as assigned
  • Oversee the project including leading the project team, communication with the client, ensuring adherence to timelines and budget responsibility, if assigned the Project Manager role for a project where no clinical Project Manager is assign

Education

  • Scientific, Informatics, Mathematics or Medical Documentation degree or equivalent combination of education and experience.

Experience

  • At least 5+ 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)

Job Type: Full-time

Pay: $65,643.00 - $141,022.00 per year

Schedule:

  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Experience:

  • REST: 3 years (Preferred)

Work Location:

  • Fully Remote

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