Study EDC Designer

hace 7 días

Xico, México Cognizant A tiempo completo

Job Summary

We are seeking a highly skilled Clinical Data Management Specialist with 8 to 10 years of experience to join our team at Cognizant. The ideal candidate will have extensive experience in Veeva RAVE Rave Data Model Rave Custom Functions and Medidata Rave. They will also possess strong domain expertise in Clinical Data Management.

Responsibilities

  • Lead the implementation of Veeva and Medidata Rave solutions to meet client requirements.
  • Oversee the customization of Rave Data Models and Custom Functions to enhance data management processes.
  • Provide expert guidance on best practices for Clinical Data Management.
  • Conduct thorough analysis of client needs and develop tailored solutions.
  • Understand study protocol and programs tests forms edit checks custom functions in EDC systems such as Rave Veeva.
  • Manage post-production changes technology changes and deviations as required.
  • Attend study design and build meetings with clinical teams and data managers.
  • Create and review study design specifications.
  • Utilizes project management tools to track study progress and plan work.
  • Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
  • Ensures that TA- and program-level consistency is achieved.
  • Interacts within department and with cross-functional team members to achieve program and study objectives.
  • Ensures that assigned work product is synchronized with upstream and downstream dependencies.
  • Ensures adherence to federal regulations and applicable local regulations Good Clinical Practices (GCPs) ICH Guidelines Standard Operating Procedures (SOPs) and to functional quality standards.
  • Stays abreast of new and/or evolving local regulations guidelines and policies related to clinical development.
  • Participates in cross-functional innovation and process improvement initiatives

Qualifications

  • Possess a deep understanding of Veeva and Medidata Rave systems.
  • Demonstrate expertise in Rave Data Model and Custom Functions.
  • Have strong experience in Clinical Data Management.
  • Certifications Required Veeva Vault Certified Medidata Rave Certified.

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