Medidata Rave Clinical Programmer-Hyderabad

  Medical Writing

Job title: Medidata Rave Clinical Programmer-Hyderabad

Company: Statistics & Data Corporation (SDC)

Job description: Job Summary

Works as part of a project team to design and implement Medidata Rave clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, data quality edit checks, and custom functions to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Communicates database build, edit check programming and related document review statuses to management and the project teams.

Primary Responsibilities

  • Assist in developing, validating, and maintaining clinical databases for clinical trials using a variety of validated software applications
  • Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans.
  • Build and validate data entry screens (Electronic Data Capture (EDC))
  • Implement and test data quality checks in accordance with the study data validation manual
  • Implement and test custom functions in support of data validation manual or eCRF matrix specifications
  • Assist in development of study specification documentation, including but not limited to data validation manual and eCRF Matrix
  • Utilize copies of like database elements from library structures or other similar studies during builds
  • Assist in management of user access to clinical databases
  • Participate in writing departmental documentation (e.g. training documents, process guidances)
  • Participate in other clinical programming and data management activities, as required
  • Adhere to all aspects of SDC’s quality system
  • Comply with SDC’s data integrity and business ethics requirements
  • Perform other duties as assigned
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

  • Excellent understanding of relational database structures
  • Fast, accurate programming skills using assorted application software
  • Excellent C# / SQL programming skills
  • Proficiency with Microsoft Excel
  • Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships
  • Able to provide both “user-friendly” and technical documentation
  • Excellent written and verbal communication skills. Able to understand and describe complex design principles.
  • Proficient with scientific / medical terminology and principles.
  • Familiarity with clinical research industry/practices not required, but desirable
  • Medidata Rave knowledge / experience not required, but desirable
  • Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge / experience not required, but desirable
  • SAS programming knowledge / experience not required, but desirable

Education or Equivalent Experience

  • Bachelor’s degree in computer science or other related quantitative or scientific discipline
  • Commensurate experience with database programming and C# programming will be considered as an alternative to a degree
  • Experience as a database or C# programming consultant highly desirable

Expected salary:

Location: Hyderabad, Telangana

Job date: Sun, 09 Jan 2022 23:24:55 GMT

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