Clinical Programmer jobs in Orange, CA

How will you make an impact?

The Clinical Programmer II will, at the direction of the Lead Clinical Programmers, design clinical study databases, program edit checks, integrate external data sources, and model and deliver data reports, dashboards and datasets. The Clinical Programmer II works in coordination with the Lead Clinical Programmer, Data Management, Biostatistics and Clinical Operation teams to develop standard operating processes in support of clinical research.

What will you do?

Database Design and Programming:

• Develop study database designs (e.g. electronic Case ReportForms) modelling design on CDISC standards.
• Implement a data cleaning strategy (e.g. edit checks, reports, etc.) in accordance to Edit Check Specifications, Data Management Plan, and Data Review Guideline.
• Ensure timely delivery of a quality locked database for analyses at the close of studies.
  Support computer system validation activities

Data Transfer Agreements:

• Create Data Transfer Agreements and manage delivery of third-party clinical data for reconciliation and cleaning.

Collaboration with Cross-Functional Teams:

• Provide ongoing day to day support to the data managers and Clinical Study Teams to ensure all systems and programs are executing correctly and efficiently, to include validating/checking programming.
• Collaborate with internal team and stakeholders to ensure deliverables meettimelines.

Process Improvement:

• Participate in the standardization of libraries for CRFs (modelling CDISC standards) and edit checks to expedite study deliverables
• Recommend technical and process solutions that can be used or developed to increase efficiency of project work

How will you get here?

• Minimum of 2 years of experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Programming or related functional area is required
• Knowledge of FDA/ICH guidelines and industry/technology standard practices
• Experience with any EDC systems platforms (e.g. MedNet, Rave, Veeva Vault EDC etc.)
• Understanding of the clinical trial process
• Experience extracting and transforming clinical data to support Reporting & Analytics
• Knowledge of standards related to Clinical Data Management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
• Experience in relational database language such as SQL
• Experience with CDISC (CDASH, SDTM) standards
• Software Development Life Cycle (SDLC) and Computer System Validation (CSV) experience
• Experience with other programming languages such as SAS, R, Python
• Experience with Data Visualization, Reporting or Visual Analytics tools preferred
• Bachelor's degree in computer science, Life Sciences, Biostatistics or equivalent degree

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.