Veeva is a mission-driven organization that aspires to help our customers in LifeSciences 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 RoleVeeva 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 and CDISC SDTM standards expertise. You are confident in your own hands-on SQL and SAS programming and knowledgeable about clinical data standards and guidelines (GCDMP, EDC configuration of eCRF’s and Edit Checks, CDISC CDASH and SDTM, FDA TCG, etc). You are equally comfortable in training and consulting customers to optimize their data review and SDTM mapping processes.In this role you will be at the forefront of our mission and responsible for four main things: First, assessing customers’ data management needs and challenges, offering guidance and direction to ensure that the clinical trial is designed with the deliverable in view. Second, understanding our customers’ clinical trial data review, mapping, and extraction requirements with the Vault CDB application adhering to Good Clinical Data Management Practices, CDISC regulatory submissions and Veeva standards to optimize value. Third, preparing and reviewing specification documents, data review listings and reports, and SDTM transformations using Veeva CDB. Finally, training and mentoring customers who are working with the Vault CDB application or are new to clinical trials.
Opportunities are available across the United States and Europe for this role; this is a remote position. There is no work location requirement if a candidate is in close proximity to an airport and able to meet travel requirements. Qualified U.S./EU based candidates are encouraged to apply.What You’ll Do
- Implement CDISC SDTM transformations and extractions by authoring and validating specification documentation, programs, and system configurations
- Establish relationships and collaborate with customer teams to understand ongoing data review and SDTM mapping requirements and standards
- Develop listings and reports 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
- Specify and produce aggregated datasets to support ad hoc operational reports not already implemented within the EDC
- Collaborate with clinical data providers (Central Laboratories, ECG, eCOA, IRT, etc.) to optimize data harmonization and aggregation in Veeva CDB
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 and SAS are required. Experience with other programming languages (R, JSON, Python, or other languages/tools) desired
- Demonstrated ability to author CDISC SDTM mapping specifications, program and validate SDTM datasets, and create Define-XML submission packages
- Knowledge of CDISC CDASH, ADaM, and Controlled Terminology standards
- 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 30%
- 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
- Knowledge of CDISC Standards CDASH amp; 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 (NJ; Boston, MA; Philadelphia, PA; Newark, NJ; Chicago, IL, Raleigh, NC)
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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.