Job Description

POSITION TITLE: Senior Clinical Programmer


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 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.


The Role:



Our Senior Clinical Programmer 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) including third-party integrations.
• 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 Ora Clinical quality system.
• Comply with Ora Clinical data integrity & business ethics requirements.
• Adherence to all essential systems and processes that are required at Ora Clinical to maintain compliance to business and regulatory requirements.
• Participate in internal and external team meetings, as necessary.
• Responsibilities may differ from the above based on the specific needs of the business.
• 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 related, scientific field.
+ 4+ 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).
+ 2+ years in a clinical environment.
• •Additional Skills and Attributes:•
+ Medidata Rave EDC Certified Study Builder Certification preferred.
+ iMedNet knowledge preferred.
+ C# and/or SAS programming knowledge/experience not required, but preferred.
+ 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:•
+ What We Do:
- Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
+ How We Do It:
- IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
- Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
+ Why We Do It:
- 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. At Ora, we are creating vision beyond what we see.

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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