Job Directory Senior Clinical Data Programmer Analyst

Senior Clinical Data Programmer Analyst
Pleasanton, CA

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Job Description

Job Description/Responsibilities:

* Medrio EDC system:
* Responsible for creation of clinical databases in Medrio to support data collection in clinical trials
* Serves as subject matter expert, super user, trainer (of internal and external users) and local support for -technical guidance or troubleshooting.
* Manages study database specification meetings involving departments relevant to the clinical trial process (e.g. CRF design meetings)
* Facilitates activities regarding the design, development, documentation, user acceptance testing (UAT) and implementation of clinical study eCRF database using Medrio.
* Maintains and enhances the RMS data collection standard CRFs, database specifications and edit checks standards library. Ensures that standard CRFs are honored and also comply with CDISC/CDASH standards.
* Drives post production changes in Medrio studies to ensure compliance with protocol amendments and internal SOPs.
* Develops RMS Medrio training materials as required.
* Serves as the user access administrator to grant access to clinical systems for internal and external business partners (ExBP/ENROLL)

* Provides customer support by triaging Medrio and ExBP issues and identifying solutions Participates in study closure activities by managing database lock with IT and access revocation
* Knowledge and experience with relational databases is required.
* Collaborate across Business Units on topics related to Medrio and user access management
* Database software development experience is required and application development and validation is strongly recommended
* Advises non-technical personnel on Medrio data retrieval and browsing of SAS generated reports.
* Familiarity with querying/reporting tools, such as Tableau, SAS, Office Analytics, etc.
* Support database development, as needed
* Perform other technical duties as requested


* B.S. degree in Computer Science or related field, or equivalent combination of education and work-related experience.
* Experience with relational databases and clinical trials
* At least 3-5 years building clinical databases with clinical data management systems (Medrio EDC preferred)
* At least 5 years of pharmaceutical, biotech, medical device and/or diagnostic industry experience
* Experience in SAS / SQL programming a plus
* Experience in a programming language (C, C++, Java etc.)
* Knowledge of GCP and FDA requirements regarding clinical data management documentation and software
* Knowledge of CDISC/CDASH standards for clinical data collection


* Experience with database builds in EDC applications (e.g. Medrio, Inform, RAVE)
* Knowledge of CDISC/CDASH standards
* SAS Programming a plus
* Project & Time Management
* MS Excel- Advanced
* MS Office/Powerpoint/Project office
* Excellent communication skills both verbal and written
* Programming language (C, C++, Java etc.)

Roche is an equal opportunity employer.

Research & Development, Research & Development > Biometrics

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