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Senior Consultant - CDMS
Posted 7 hours 10 minutes ago by Veeva Systems, Inc.
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 Management System (CDMS) is changing the way clinical data is managed in the industry. Vault CDMS combines Electronic Data Capture (EDC), coding, data cleaning, and reporting into one application. Gone are the days of complex integrations that limit clinical data availability, as Vault CDMS enables research teams to make faster and more informed decisions.
As a key member of our CDMS Professional Services team, the Senior Consultant will be at the forefront of our mission to transform the life sciences industry. You will act as the customer's trusted advisor to ensure that the study trial design is configured in such a way that it meets their goals and offers the full benefits of Veeva's CDMS application.
This is a Work Anywhere position - you can choose to work remotely in the EU, or in one of our EU offices. Veeva Systems does not anticipate providing sponsorship for employment visa status for this position.
What You'll Do
- 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.
- 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).
- Hands-on data management experience.
- Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies.
- Experience with defining data standards and libraries.
- Life Science, computer science, or related degree.
- SaaS/Cloud experience in the delivery of clinical trials.
- Experience with training for clinical sites and at investigator meetings.
- Fluency in one or more of the following languages: German, French, Spanish, Italian.
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 .
Veeva Systems, Inc.
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