At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.

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.

Some customers select Veeva Services for the build of CDMS, while our Enablement Customers want to create that capability internally. For those Enablement Customers, Veeva guides them through an Enablement process that results in the knowledge and capability necessary to independently complete builds and manage studies. Historically Enablement customers have done a lift-and-shift adoption of EDC systems. With Vault CDMS, we aim to help our Enablement customers realize the value of cloud technology and new approaches in Clinical Data Management.

We are looking for Senior Consultants who have the technical, data management, and EDC expertise needed to help our Enablement customers quickly master Vault CDMS. The ideal candidate will be well versed in the technical aspects of EDC such as eCRF design, edit checks, coding configuration, monitoring/review plans, system reporting/dashboards, etc. Additionally, this role should fully understand the clinical data management processes and industry standards (GCDMP, CDISC, SDTMIG, CDASH). The combined experiences and expertise will be used to guide our customers in not only adopting Vault CDMS, but in understanding how to leverage it towards more efficient and effective implementations.

What You'll Do

• Engage with existing Vault CDMS customers or potential customers on their data management challenges and determine how Vault CDMS can alleviate current obstacles.
• Be assigned as the Mentoring Lead for at least one Veeva Vault CDMS Enablement customer, providing Veeva best practices and application expertise.
• Creating a customized plan to guide each customer through the enablement process
• Deliver mentoring sessions/workshops to help customers understand the suggested way of working and key value statements for each module of Vault CDMS. This is typically done after the customer has already completed functional eLearning’s (i.e. the point-and-click).
• Consulting the enablement customer on key designs/approaches/problem solving when appropriate.
• Attending scheduled “office hours” with enablement customers to answer questions and provide guidance as needed.
• Creating new content/materials as-needed for the enablement program as new features are delivered.
• Participate in Veeva study builds (ideally 1 study per major release) in order to stay current with process/feature changes.
• Collect and curate feature requirements from Enablement customers, and communicate those requests to the Vault CDMS Product team.
• Share data management experiences and educate fellow Vault CDMS team members on CDM standards and guidelines.
• Attend appropriate CDM conferences and/or customer data management on-site discussions as deemed necessary.
• Notify project management of project risks and develop contingency plans as necessary
• Participate and contribute to process product or best practices initiatives
• Adherence to all Veeva and CDMS Services procedures and policies

Requirements

• 10+ years of experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting), including 2+ years in a Lead capacity (i.e. accountable to study designs and/or overall implementation of EDC).
• Ability to lead enablement engagements in an agile environment where process/responsibilities and deliverables may vary by engagement.
• Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results.
• Strong industry understanding including (but not limited to) how different customer segments operate (pharmaceutical, biotech, CRO and Medical Device), relevant business unit procedures and how they relate (Clinical, Data Management, Monitoring, Safety, etc.), key industry standards/guidelines and how they are applied (GCP, ICH, CDISC) and relevant life sciences compliance and computer system validation practices.
• Excellent verbal and written communication, interpersonal, and presentation skills
• Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Nice to Have

• Active CDM society memberships (ie, CCDM®).
• Direct experience with EDC systems.
• Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
• Life Science, computer science or related degree
• Enterprise experience and knowledge transfer for running clinical trials with EDC

Perks & Benefits

• Flexible PTO
• Allocations for continuous learning & development
• Health & wellness

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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.