System Designer lV EDC, RAVE, Veeva / Clinical
Company: Alpha Consulting
Posted on: May 24, 2023
SYSTEM DESIGNER LV EDC, RAVE, VEEVA / CLINICAL 100% Remote.
- 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
- Our operational model is exemplified through execution and
- This role is key to ensuring successful delivery against the
program- and study-level accountabilities assigned to Data and
- 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
- 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
- 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
- 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
- Stays abreast of new and/or evolving local regulations,
guidelines and policies related to clinical development.
- Responsible for coaching and mentoring Data Science
- Participates in DSS and cross-functional innovation and process
- Improve upon industry knowledge and best practices. Required
- Bachelor's degree in business, management information systems,
computer science, life sciences or equivalent. Master's
- 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
- 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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