Job Description

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. 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.

#LI-Remote

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 the 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 the 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\xe2\x80\x99s quality system

• 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 \xe2\x80\x9cuser-friendly\xe2\x80\x9d 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 the clinical research industry/practices is not required, but is 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 is desirable

• Bachelor\xe2\x80\x99s 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

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, and offer a flexible work schedule, engaging work culture, and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with a fun and engaging activities from SDC\xe2\x80\x99s culture club.
• We are constantly growing and innovating to support our clients and employees\' needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Training & Development
• Work From Home
• Profit based incentive

Statistics & Data Corporation (SDC)