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EDC IT Platform Engineer

1-2 Years
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  • Posted 5 days ago
  • Over 50 applicants
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Job Description

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

More Info

Job Type:
Employment Type:
Open to candidates from:
Indian

About Company

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet

Job ID: 118224645

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