Our client is a leading medical device company in the field of non-invasive surgical treatments. They are looking for a Clinical Database Specialist to be based in their main office in Dallas TX.
?Experience with at least Oracle Clinical programming hands-on experience, TSQL, Databases (Oracle, SQL), at least one programming/Scriptinglanguage (C#, VB etc.).
? Familiarity/knowledge of FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems are desirable
?Experience developing applications (web or otherwise) in the context of research studies; Familiarity with an Electronic Data Capture (EDC) system such as Oracle Clinical, Medidata RAVE?, or other EDC systems a plus;
? Working knowledge of clinical and epidemiological research and implementation of data collection systems.
?Responsible for leading and/or supporting database build activities for EDC clinical studies and related setup tasks including eCRF/study design, edit check programming, randomization, coding setups, external data import setups, listings/report development as needed following the appropriate company SOPs.
? Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (eCRF)s, database creation, coding setup, randomization, edit check procedures, import, export setup and processing including SAS and/or Excel datasets, listings, reporting requirements.
? Assists in User Access Management for Data Management/Clinical systems as required.
? Develop & maintain reporting & analytics
? Proactively provides process improvement feedback to Management and provide input in SOP updates/development.
? Participate in Internal/External audits as required.
? Assist in developing programming related timelines.
? Provides technical support on Data Management/Clinical systems including CDMS (EDC) packages such as Oracle, Rave, reporting tools, custom functions, etc.
? Proactively monitors internally and externally hosted applications for performance and/or system errors.
? Assists in addressing external application vendor issues, integrations, and implementations
? Assists in managing workload by reviewing status updates and study metrics.
? Provides relevant training, guidance, and support to peers and other department members as required
? Collaborates with clients, peers, project teams and/or requestors to clarify and finalize specifications and uses technical skills to meet evolving project needs.
? Provides support to senior and manager level clinical databaseprogrammers as needed.
? Provides Support for Implementation of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas.
? Maintains and continues to gain a broad overall knowledge in the field of clinical programming and clinical data management.
? Performs other work-related duties as assigned.
? Must be willing to travel, around 20% of their time.
? Ensure that all standards are met and maintained as per SOPs, ICH and GCP guidelines.