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System Designer lV EDC, RAVE, Veeva / Clinical

Company: Alpha Consulting
Location: Remote
Posted on: May 24, 2023

Job Description:

SYSTEM DESIGNER LV EDC, RAVE, VEEVA / CLINICAL 100% Remote. Project Description:

  • Our client is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data.
  • Our operational model is exemplified through execution and innovation.
  • This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
  • The EDC Lead Ensures that the requirements of each study protocol are reflected in EDC systems designs(Veeva EDC/ Medidata RAVE) and that common data standards(CDASH/SDTM) are used effectively.
  • Accountable for the High Quality, CDASH Conformance, on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to EDC clinical systems.
  • 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.
  • Proven ability to manage more complex study protocols.
  • Ensures that systems are specified to optimize functionality, end user experience, and data flow.
  • Ensures that the eCRF design best practice and EDC best practices are adhered to.
  • Participate in the creation of standards, either through tools, libraries, or processes, as required to ensure efficient, effective, and optimal processes.
  • Develop, improve, and implement project specific tools.
  • Ensures that TA- and program-level consistency is achieved.
  • Interacts with and influences DSS and 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 Clinicalandices (GCPs), ICH Guidelines, company 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.
  • Responsible for coaching and mentoring Data Science Associates.
  • Participates in DSS and cross-functional innovation and process improvement initiatives.
  • Improve upon industry knowledge and best practices. Required Skills:
    • Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's preferred.
    • Must have 5+ years of clinical technology experience (e.g., EDC) or 7+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred.
    • Veeva EDC Expertise Required, Veeva Studio Certification a plus, Medidata RAVE Expertise a plus.
    • Demonstrated understanding of clinical trial process.
    • Good Understanding of implementing CDASH Conformant eCRFS Required SDTM Knowledge a plus.
    • Collaborative and Proactive.
    • Demonstrated ability to influence others without direct authority.
    • Demonstrated effective communication skills.
    • Demonstrated effective analytical skills. This 6+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #23-00974 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting, Eugene , System Designer lV EDC, RAVE, Veeva / Clinical, Healthcare , Remote, Oregon

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