* 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
Let your dream job find you.
Sign up to start matching with top companies. It’s fast and free.