Job Description

POSITION: SR. CLINICAL DATABASE PROGRAMMER ANALYST  (MEDRIO EDC)

LOCATION: PLEASONTON, CA DURATION: 3-5 YEARS CONTRACT

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

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.)

Company Description

MaxisIT® is the Clinical Software Organization & only Integrated Software Platform for Biopharmaceutical industry.