Sr Clinical Data Programmer

Location: Pleasanton, CA, United States
Date Posted: 07-12-2017
Job Title :Sr Clinical Data Programmer
Location : Pleasanton, CA​​.
Requisition #: 7310652


 
 
Job Description/Responsibilities:
Medrio EDC system:
o    Responsible for creation of clinical databases in Medrio to support data collection in clinical trials
o    Serves as subject matter expert, super user, trainer (of internal and external users) and local support for -technical guidance or troubleshooting.
o    Manages study database specification meetings involving departments relevant to the clinical trial process (e.g. CRF design meetings)
o    Facilitates activities regarding the design, development, documentation, user acceptance testing (UAT) and implementation of clinical study eCRF database using Medrio.
o    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.
o    Drives post production changes in Medrio studies to ensure compliance with protocol amendments and internal SOPs.
o    Develops RMS Medrio training materials as required.
o    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 solutionsParticipates 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 requiredand application development and validation is strongly recommended
·         Advises non-technical personnel on Medriodata 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

Requirements:
·         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

Skillsets:
·         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.)




Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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