Remote Senior Consultant - CDMS

Summary

Join Veeva Systems, a mission-driven organization and pioneer in industry cloud, as a Senior Consultant on the CDMS Professional Services team. The role involves leading requirements-gathering sessions, understanding customers' data management needs, and implementing study designs with the Vault CDMS application. As a key member of our team, you will act as the customer's trusted advisor to ensure that the study trial design meets their goals and offers the full benefits of Veeva's CDMS application.

Requirements

• 5+ years experience in end-to-end data management-related activities in EDC (database design and configuration, data collection, data analysis, query resolution, datasets, statistical reporting)
• Experience in interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation
• Experience in designing forms and rules in EDC, as well as understanding how data is managed, cleaned, and reported
• Strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH)
• Experience in a customer-facing role, preferably with a software professional services or consulting organization
• Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
• Ability to travel up to 25% (may include international)

Responsibilities

• Lead requirements-gathering sessions to understand 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, create specifications, and implement a study design with the Vault CDMS application
• Adhere to Good Clinical Data Management Practices and Veeva standards to optimize value
• Author all specification documents used by team members and configure Veeva products during the development phase of the project
• Train and mentor customers and clinical sites who are working with the Vault CDMS application or are new to clinical trials
• Support the requirements gathering and specification creation process for all study integrations
• Lead customer requirement and testing sessions
• Notify project management of project risks and develop contingency plans as necessary
• Deliver post go-live configuration changes