Senior Clinical Programmer (Medidata)

SDC is a diversified professional team delivering exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance, and 401k matching (US), we are able to attract some of the most talented people in the industry.

This person will work as part of a project team to design and implement Medidata Rave clinical database applications in support of clinical research and biostatistics analysis. As well as work with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. They will develop data entry screens and programs, data quality edit checks, and custom functions to comply with related specifications, accomplish database structure testing, processes database programming change requests, document all work fully according to FDA regulations/guidances, and company SOPs, communicate 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 Medidata Rave, including Core Configuration settings
• 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/modify and test custom functions in support of data validation manual
• Assist in developing and maintaining global library of clinical database forms, edit checks, and other regularly used programs and routines
• Utilize copies of like database elements from library structures or other similar studies during builds
• Work with SDC IT and vendors to integrate external data, including IWRS, ePRO, clinical labs, with Medidata systems – using either Batch Uploader or RWS
• Track issues in Medidata applications, work with Medidata to resolve, and escalate issues appropriately to senior management.
• Participate in internal and external team meetings, as necessary
• Assist in implementation of other Medidata applications with Rave (e.g. RTSM, CTMS, eCOA, tSDV)
• Assist in management of user access to clinical databases using iMedidata & Cloud Administration
• Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug
• Participate in writing departmental documentation (e.g., training documents, process guidances)
• Participate in other clinical programming and data management activities, as required
• Mentor junior level Rave clinical programmers

Requirements

• At least six years experience assuming lead database programming responsibilities on projects, with a minimum of 3 years in using Medidata Rave
• Excellent understanding of relational database structures
• Fast, accurate programming skills using assorted application software
• C#, PL/SQL, SQL, and XML programming skills
• Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships
• Demonstrated ability to provide both “user-friendly” and technical documentation
• Ability to provide expertise to guide the department in continued efficiency and growth
• Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP)
• Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment
• C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge/experience not required, but highly desirable
• Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge/experience not required, but desirable

Education or Equivalent Experience