Medidata Rave Clinical Programmer

6 days ago

Hyderabad, India Statistics & Data Corporation (SDC) Full time

**Medidata Rave Clinical Programmer**

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

**Summary**:
**Primary Responsibilities**
- 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.

**Requirements**:
**Required Skills**:

- Excellent understanding of relational database structures
- 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

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

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