Job
Description
Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testingof the Core EDC Product,and anydata integrations (in and out)of EDC. Perform impact analysis for any change that happens on the EDCsystem Work with business and perform risk assessment during change implementations/systemupgradesor updates tointegrations Follow andparticipatein validation lifecycle for upgrades, changes, & new integrations Co-develop validation packagesin accordance withstandard operating procedures (SOPs). Provide support of code review and solutioningfor downstream customer requirements, including data extraction methods (SQL, Webservices, APIs) Activelyparticipatein business meetings and bringnew ideasto thetable Responsibleto solveday-to-day incidents, service requests andworktowards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests,changesand problems. Constantly thrive to learn and upskill according to the organization s goals and demands. CreateGxpValidation Test cases inJiraXrayfor system/upgradetesting Perform validationtest executions in Jira Xray,for bothsystem testingand regression testing. Assistin creating or create UAT test cases that cover the essential business scenarios/use casesfor the business. Facilitateprocess requirementsgathering:capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration. Mandatory Skills Extensive experience of usingMedidataRAVE UI(Classic or Rave EDC)to perform the following actions: Study build, edit checks programming, deployment to production andmigration Understanding aboutdifferent rolesand permissions in Rave Understanding of core configuration and clinical views Understanding of what data extraction capabilities there are Hands on Experience of Inbound Rave Web Services (egIVRS or discrepancy inputs) Experience of setting up Rave safety gateway (RSG) and SAE notifications Experience of setting up SAS extracts Experience on setting up Target Source Data Verification (TSDV) Hands on experience of being involved in URL upgrade(s) (Medidata release updates) Knowledge on system validation process / Application Life Cycle Management Must havestrong communicationskills and interpersonalskills Responsible to work on technical tasks to keep the Rave URL(s) andit sintegrations in a maintained state Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc. Working experience in clinicalstandard anddatacollection, clinical data conversion or clinical data programming/testing. Understandingof CDASH, SDTM,ADaMCDISC controlled TerminologyandFDA/ICH guidelines for clinical studydata Effective in stakeholder management, translating technical concepts, and working within team environments. Skilled in project management basics and creating clear technical documentation. Preferred Skills Hands on Experience of custom function,SASprogramming 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,sqlscript writing, stored procedures Hands-on knowledge in agile management tools like Service NOW Hands-on experience in performing system testing including authoring and executing testcases Passion for learning, innovating, and delivering valuable software to people. Any other programming languages/technical skillse.g: Python, JAVA, etc. Knowledge of other Medidata products and/or Cloud EDCtesting(Rave/Inform/Veeva)experience. Educational Requirements Bachelor or master sdegree in computer science or life science related discipline with IT/CRO/Pharma experience with total of8+ years of experience
