Veeva4mo ago

Senior Consultant - CDMS Services (eCOA)

TokyoFull-Timesenior

OtherConsultant

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Quick Summary

Overview

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.

Technical Tools

OtherConsultant

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is managed in the industry. Veeva eCOA is cutting edge applications which give flexibility to the customer to capture data directly patient or physician and operating as stand alone application without base application like EDC. Veeva eCOA can support customer to capture data directly via app and/or web.

Work with customers to review and understand clinical protocol requirements and prepare, review, and finalize all project specifications applying industry and Veeva best practices

Configure Questionnaire and surveys to meet study requirements

Conduct on-site or remote user acceptance testing with the customer including coordination of all feedback, resolution of issues, and acceptance of the study

Support requirements gathering and specification creation for eCOA study set up, all study go live activities, and post go live study support

Act as the customers' trusted advisor to ensure that the study trial design is configured in such a way that it meets the customer’s goals and offers the full benefits of Veeva’s eCOA application

Notify project management of project risks, develop contingency plans as necessary, assure process compliance with all regulatory and Veeva procedural requirements

Participate and contribute to process product, or best practices initiatives, and support developers and testers during the project lifecycle

5+ years’ experience in eCOA project (study design, license holder management, device provisioning etc.)

Life sciences industry experience and knowledge of clinical trial processes (pharmaceutical, biotech, medical device companies, CRO’s, clinical IT vendor and academic & public health organizations) as they relate to design, document, and data collection – demonstrated success with customers during project assessment, planning, development, training and implementation.

Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred

Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team

Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results

Excellent verbal and written communication, interpersonal, and presentation skills

Native Japanese and fluent English

Json programming

Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation

Working understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).

Experience working with system integrators for EDC, IRT, medical coding, eSource, CTMS, eTMF, and other clinical technologies

Life Science, computer science or related degree

Familiarity with CDISC, ODM, and other data management industry standards

SaaS/Cloud experience in the delivery of clinical IT solution

Experience with training for clinical sites and at investigator meetings

Consulting experience

Veeva Giving. Financial contributions for the societal causes you’re passionate about

Health & wellness programs

Flexible PTO and company-paid holidays