Senior Consultant - CDMS Services (EDC)

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 a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

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 application is a clinical data and randomization/drug supply management and patient engagement system in the pharmaceutical industry. Vault Clinical Data Application combines EDC, CDB, RTSM, and ePRO. These applications support clinical trials conducted successfully with high qualify and efficiency. As a result, clinical trials can be finished fast.

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
• Participate in Product team discussions to convey customer activities, challenges, and end-user expectations
• Configure systems and support the customer for project success
• 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 process for all study integrations and go live activities for the study to ensure a smooth transition of the study to the customer
• Act 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 Clinical Data application
• Notify project management of project risks and develop contingency plans as necessary and 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

• 2+ years’ experience in IT industry experience
• 2+ years’ experience working with software solutions
• 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 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
• Ability to travel 20-25% (may include international)

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 IVRS, 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 trials
• Experience with training for clinical sites and at investigator meetings
• Consulting experience