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
