Senior Clinical Programmer (Rave)

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POSITION TITLE: Senior Clinical Programmer (Rave)

DEPARTMENT: Data Management

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

The Role:

Our Senior Clinical Programmer (Rave) will work as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis.  This individual will work with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing.  They will also develop data entry screens and programs, and data quality edit checks to comply with related specifications. In addition, they will handle database structure testing and process database programming change requests while documenting all work according to FDA regulations and guidance, and company SOPs. They will actively promote standards for the development and acquisition of systems as well as communicate with end-users. Mentors/trains junior level clinical programmers.

What You’ll Do:

• 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.
• 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.
• Batch load external data from vendors (e.g., central lab data).
• Assist in management of user access to clinical databases.
• 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 guidance).
• Participate in other clinical programming and data management activities, as required.
• Mentor junior level clinical programmers.
• Adhere to all aspects of the Statistics & Data Corporation’s quality system.
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements.
• Perform other related duties incidental to the work described herein.
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.
• Participate in internal and external team meetings, as necessary.
• Clear and sustained demonstration of the Ora Clinical Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

What We Look For: 

Experience needed for the Role: 

• Bachelor’s degree in computer science or other quantitative or scientific discipline.
• Medidata Rave EDC Certified Study Builder Certification.
• 6+ years’ experience assuming lead database programming responsibilities on projects (commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree).
• 3+ years in a clinical environment.
• C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge/experience not required, but preferred.
• Medidata Rave EDC knowledge experience with valid Rave Certification; iMedNet knowledge is not required, but desirable.
• PL/SQL, SQL, and XML programming skills.

Additional Skills and Attributes:

• Excellent understanding of relational database structures.
• Fast, accurate programming skills using assorted application software.
• Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment.
• Solid interpersonal skills, with the ability to work well with people of all levels of expertise.
• Demonstrated ability to provide both “user-friendly” and technical documentation.
• Ability to provide expertise to guide department in continued efficiency and growth.
• Knowledge and experience with FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP).
• Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge / experience not required, but preferred. 

Competencies and Personal Traits:

• Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
• Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
• Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
• Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
• Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
• Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
• Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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