You will facilitate key discussions with various stakeholders, provide SME technical support on system testing of the Core EDC Product, and manage data integrations. You will perform impact analysis for any changes to the EDC system and work with the business to perform risk assessments during change implementations/ system upgrades or updates to integrations. You will also co-develop validation packages in accordance with standard operating procedures (SOPs) and provide support of code review and solutioning for downstream customer requirements.
Essential Skills/Experience:
Extensive experience of using Medidata RAVE UI
Hands-on experience of being involved in URL upgrade(s)
Knowledge on system validation process / Application Life Cycle Management
Strong communication skills and interpersonal skills
Working experience in clinical standard and data collection, clinical data conversion or clinical data programming/testing.
Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology and FDA/ICH guidelines for clinical study data
Hands on Experience of custom function, SAS programming
Knowledge on Coder / Coder+ setup & Lab setup
Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter)
Hands on Experience of Rave backend data model, sql script writing, stored procedures
Hands-on knowledge in agile management tools like Service NOW
Hands-on experience in performing system testing including authoring and executing test cases
Passion for learning, innovating, and delivering valuable software to people.
Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 5+ years of experience
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