Senior Consultant - CDMS Services (eCOA)
PharmaBiotechCROMedTechClinical ResearchRegulatory Affairsveevaclinical data managementcdmedccroctms
Job description
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. What You’ll Do
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 Requirements
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 Nice to Have
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 Perks & Benefits
Veeva Giving. Financial contributions for the societal causes you’re passionate about
Health & wellness programs
Flexible PTO and company-paid holidays
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