Clinical Programmer

SDC Clinical; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

SDC is seeking a Clinical Programmer in Hyderabad to join a project team designing and implementing clinical database applications for trials and biostatistics. You will work with data managers and biostatisticians to develop build specifications and acceptance via user testing.

Responsibilities include building data entry screens, quality checks, and documentation, while adhering to FDA regulations and SDC procedures.

Qualifications

• Bachelor's degree in computer science or related quantitative discipline.
• Experience in clinical database programming and database administration preferred.
• Excellent written and spoken communication skills.
• Strong understanding of relational databases and data management.

Responsibilities

• Assist in developing, validating, and maintaining clinical databases for trials.
• Provide complete documentation of study databases in SOPs and protocols.
• Build and validate data entry screens (EDC) and admin interfaces.
• Implement and test data quality checks per validation manuals.
• Collaborate with data managers and biostatisticians on build specs.
• Ensure adherence to FDA regulations, guidance, and SDC quality system.
• Manage user access and participate in departmental documentation.
• Support other clinical programming and data management activities as required.

Skills

Relational databases

Programming skills

PL/SQL

XML programming

Documentation

Communication skills

C++, .NET, SAS (desirable)

Education

Bachelor's degree in computer science or related field

Job description

Clinical Programmer

Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Works as part of a project team to design and implement 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, and data quality edit checks 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 (paper and/or electronic data capture (EDC))
• Implement and test data quality checks in accordance with the study data validation manual
• Utilize copies of like database elements from library structures or other similar studies during builds
• Assist in batch loading external data from vendors (e.g., central lab data)
• 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 the SDC s quality system
• Comply with SDC s data integrity 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
• 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
• Able to provide both user-friendly and technical documentation
• Excellent written and verbal communication skills
• C++, .NET, Visual Basic or other object-oriented language, and/or 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 clinical database programming and database administration will be considered an alternative to a degree.

Why SDC

SDC is a team of diversified professionals who deliver 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 and positive work/life balance, we are able to attract some of the most talented people in the industry.

• - We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, 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 fun and engaging activities from SDC s culture club.
• - We are constantly growing and innovating to support our client and employee 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.

Take a look at how you can join our team!

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Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.