Principal Clinical Programmer

1 month ago

San Clemente, United States Glaukos Corporation Full time

How will you make an impact?


The Principal Clinical Programmer will oversee multiple clinical trial programs, designing study databases, programming edit checks, integrating external data sources, and modeling and delivering data reports, dashboards and datasets, including resourcing to ensure timely high-quality deliveries. The Principal Clinical Programmer will also serve as a mentor for junior team members. Where required, the Principal Clinical Programmer will lead individual programs. In partnership with the Data Management, Biostatistics, and Clinical Operations teams, the Principal Clinical Programmer will develop standard operating processes in support of Clinical Research, identifying, implementing and owning clearly communicated standards for the creation of repeatable, efficient, industry-leading work product.


What will you do?

  • Clinical Programming Team Resourcing and Company's Business Objectives:
    Oversee resourcing needed to support clinical programming activities on multiple clinical studies.
  • Develop and execute on clinical programming goals to support the Company's Business Objectives and principles.

Database Design and Programming:

  • Oversee the development of study database designs (e.g. electronic Case Report Forms) for multiple clinical trial programs, modelling design on CDISC standards.
  • Oversee (including lead, as needed) the implementation of data cleaning strategies (e.g. edit checks, reports, etc.) in accordance to Edit Check Specifications,Data Management Plan, and Data Review Guideline for multiple clinical trial programs
  • Oversee (including lead, as needed) the timely delivery of a quality locked database for analyses at the close of studies.
  • Oversee (including lead, as needed) clinical programming deliverable activities and timelines (e.g., EDC, Edit Checks, Reports, Dashboards, SDTM datasets, etc.) for multiple studies. Lead computer system validation activities.
  • Oversee the identification, information gathering, requirements document development and system validation of external technologies.


Collaboration with Cross-Functional Teams and other Clinical Programmers:

  • Collaborate with internal team and stakeholders to ensure deliverables meet timelines.Collaborate with other Clinical Programmers to identify and initiate discussions with EDC providers on requested system functionality / configurability updates.
  • Collaborate with other Clinical Programmers on reviewing EDC system updates for impact on current builds and identify mitigating actions and testing as needed.
  • Oversee the ongoing day to day support to Data Managers and Clinical Study Teams to ensure all systems and programs are executing correctly and efficiently, to include validating/checking programming.
  • Present on clinical programming topics at in-house meetings/trainings.


Process Improvement:

  • Lead the standardization of libraries for CRFs (modelling CDISC standards) and edit checks to expedite study deliverables.
  • Lead the recommendations and implementations of technical and process solutions that can be used of developed to increase efficiency of project work.
  • Stay current with industry trends and emerging technologies in clinical programming.
  • Conduct regular reviews of clinical programming activities to maintain high-quality stand-ards

Vendor Management:

  • Coordinate and manage relationships with external vendors providing data management services.
  • Oversee the selection, qualification, and performance of third-party vendors.
  • Oversee the Management of service providers (e.g., Labs, Medical Coders) to ensure agreed upon performance on quality and timeliness of deliverables.
  • Oversee (including lead, as needed) the creation of Data Transfer Agreements and manage delivery of third-party clinical data for reconciliation and cleaning.

How will you get here?

  • Minimum of 12 years of experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Programming or related functional area required.
  • Understanding of FDA/ICH guidelines and industry/technology standard practices.
  • Experience with any EDC systems platforms (e.g. MedNet, Rave, Veeva Vault EDC etc.).
  • Deep and broad clinical programming experience in the life sciences industry (e.g. Device, Biopharmaceutical, Biotech, CRO companies.
  • Experience with Data Visualization, Reporting or Visual Analytics tools
  • Demonstrated depth of understanding of the clinical trial process.
  • Experience extracting and transforming clinical data to support Reporting & Analytics.
  • Demonstrated multi-tasking, problem-solving and verbal and written communication skills essential.

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.

#LI_Remote #GKOSUS

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