Veeva

Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.

The Role

Veeva CDB is a clinical data platform that aggregates and harmonizes all data sources to provide our customers with clean, well-organized data that is ready to use faster. Gone are the days of complex integrations that limit clinical data availability, now research teams can make faster and more informed decisions.

Veeva Systems is looking for Senior Consultants who have deep data management expertise and are experienced in helping customers optimize the use of cleaning listings and reporting in running their clinical trials. You strongly understand SQL and configuration (eCRFs, Edit Checks, etc). We’re looking for a Consultant that also has a level of understanding of clinical data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).

In this role you will be at the forefront of our mission and responsible for four main things: Firstly, assessing customers’ data management needs and challenges, offering guidance and direction to ensure that the clinical trial is designed with the deliverable. Furthermore, understand our customers’ clinical trial protocol requirements to implement a study design with the Vault CDMS application, while adhering to Good Clinical Data Management Practices and Veeva standards to optimize value. Lastly, authoring all specification documents used by team members and configuring the study design during the development phase of the project. Finally, training and mentoring customers and clinical sites who are working with the Vault CDMS application or are new to clinical trials.

Opportunity is available in the United States and Europe for this role. The work location is remote within the U.S and Europe. The qualified U.S. and Europe-based candidates are encouraged to apply.

What You'll Do

• Develop listings to implement data cleaning specifications (e.g., required fields, range checks, data type checks, and within-and across-record logic checks) using SQL-based language
• Collaborate with Clinical Study Teams to identify additional data cleaning requirements based on commonly identified issues and feedback from participating sites
• Develop outlier programs to identify data that may exceed actual and logical limitations of each data element and produce reports specifying possible and probable errors contained in the data (e.g., invalid data, missing data, and data in conflict with the within- and across-record logic checks)
• Assist in creating aggregated datasets; develop and execute ad hoc operational reports not already implemented within the EDC
• Collaborate with clinical data providers (Central Laboratories, ECG, eCOA, IRT, etc.) to receive data and test the transfer based on requirements

Requirements

• 4+ years of in-depth understanding of data collection, data flow management, data quality, data extraction, and data standards
• Excellent programming skills in SQL are required. Experience with multiple programming languages (SAS programming language, R, JSON, or other languages/tools) desired, including the creation of EDC database development
• Knowledge of CDISC Standards CDASH & SDTM, and ADaM knowledge is a plus
• Working Knowledge of clinical trial processes across pharmaceuticals, device, and biotech sectors, specifically as they relate to document and data collection
• Proven ability to manage diverse stakeholders, and ensure delivery to a high degree of satisfaction
• Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team where you need to “roll up your sleeves” to implement a clinical solution
• Ability to travel up to 50%

Nice to Have

• Knowledge of CDISC Standards CDASH & SDTM, ADaM knowledge SaaS/Cloud experience
• Life Science, computer science, change management, or related degree
• Experience with Veeva applications
• Locality to major life sciences customer hub

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

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.