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 $2B 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 apublic benefit corporation(PBC), legally bound to balancing the interests of customers, employees, society, and investors. As aWork Anywherecompany, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us intransforming 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. Vault CDMS combines EDC, coding, data cleaning, and reporting into one application. Gone are the days of complex integrations that limit clinical data availability, now research teams can make faster and more informed decisions. Veeva Systems is looking for Consultants who have life sciences software configuration experience, specifically in helping customers optimize the use of EDC in running their clinical trials. EDC design and configuration experience and a working understanding of how data is managed, cleaned, and reported. As a key member of our CDMS Professional Services team, the Consultant will be at the forefront of our mission and responsible for four main things: Understanding customers' data management needs and challenges, offer guidance and direction to ensure that the clinical trial is designed with the deliverable in view. Understand our customers' clinical trial protocol requirements to implement a study design with the Vault. CDMS application adheres to Good Clinical Data Management Practices and Veeva standards to optimize value. Responsible for authoring all specification documents used by team members and configuring the study design during the development phase of the project inclusive of forms, rules, and study configuration. What You'll DoWork with customers to review and understand clinical protocol requirements and prepare, review, and finalize all project specifications applying industry and Veeva best practicesParticipate in Vault CDMS Product team discussions to convey data management activities, challenges, and end user expectationsConfigure forms, rules, and other study items with Veeva Vault CDMS product during developmentSupport developers and testers during the project lifecycleSupport the requirements gathering and specification creation process for all study integrationsConduct on-site or remote user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the studySupport go-live activities for the study to ensure a smooth transition of the study to the customerReview requirements as part of the change management process and update specifications and configurations as necessary with associated scoping activitiesAct as the customer's 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 CDMS applicationNotify project management of project risks and develop contingency plans as necessaryEnsure customer success from beginning to end of the project life cycleAssure process compliance with all regulatory and Veeva procedural requirementsParticipate and contribute to process product or best practices initiativesRequirements2+ years' experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)2+ years' direct experience working with EDC clinical software solutions in clinical operations and/or trial management in a project management/consultant roleLife sciences industry experience and knowledge of clinical trial process preferred (pharmaceutical, biotech, medical device companies, CRO's, and academic & public health organizations)Experience in a customer-facing role, preferably with a software professional services organization or consulting background, is preferredWorking Knowledge of Clinical Trial processes across pharmaceuticals, device, and/or biotech sectors, specifically as they relate to design, document, and data collectionAbility to quickly understand business requirementsProven ability to work independently in a dynamic environment but also as part of a teamLogical approach to problem solvingAbility to manage multiple tasks and project deliverablesProven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality resultsDemonstrated success with customers during project assessment, planning, development, training, and implementationExcellent verbal and written communication, interpersonal, and presentation skillsAbility to travel 20-25% (may include international)4-year college degree requiredNice to HaveExperience in interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentationWorking understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH)Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologiesLife Science, computer science, or related degreeFamiliarity with CDISC, ODM, and other data management industry standardsSaaS/Cloud experience in the delivery of clinical trialsExperience with training for clinical sites and at investigator meetingsConsulting experiencePerks & BenefitsAllocations for continuous learning & developmentHealth & wellness programs#RemoteSpain Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at******.
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