EDC IT Platform Engineer

KeyResponsibilities:

• 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