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. There are options for working from 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.
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 have a strong understanding of SQL and configuration (eCRFs, Edit Checks, etc). Were 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: 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 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. Third, 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.
This is a remote, full-time permanent role with Veeva. Veeva is a Work Anywhere company and our work processes are designed so that you can be productive in the environment that works best for you. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.
Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT)
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.
- 4+ years of in-depth understanding of data collection, data flow management, data quality, data extraction, and data standards
- Excellent programming skills in SQL is 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, ADaM knowledge as a plus.
- Working Knowledge of clinical trial processes across pharmaceuticals, device, and/or 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
Veevas 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.