Senior Consultant - CDMS Services (EDC)
China - Shanghai
Professional Services – 610-Stgy R&D /
Full-Time /
On-site
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 EDC, coding, data cleaning, and reporting into one application. The days of complex integrations limiting clinical data availability are gone; now, research teams can make faster and more informed decisions.
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 Vault CDMS Product team discussions to convey data management activities, challenges, and end-user expectations
- Configure forms, rules, and other study items with Veeva Vault CDMS product during development
- 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 CDMS 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 the process of the product or best practices initiatives and support developers and testers during the project lifecycle
Requirements
- 2+ years’ experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
- 2+ years’ experience working with EDC clinical software solutions in clinical operations and/or trial management in a project management/consultant role
- Life sciences industry experience and knowledge of clinical trial processes (pharmaceutical, biotech, medical device companies, CRO’s 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
- 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
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
