Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the worlds largest pharmaceutical companies to emerging biotechs. Veevas software helps our customers bring medicines and therapies to patients faster.

We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.

Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - its up to you.

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 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. 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.

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

#LI-Remote

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. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [email protected]. Position may not be eligible for remote work in Colorado.