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.
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.
Veeva Systems is looking for Senior Consultants who have deep data management expertise and are experienced in helping customers optimize the use of EDC in running their clinical trials. Designing forms and rules in EDC is one facet of the required skill set but also understanding how data is managed, cleaned and reported is equally important. Were looking for EDC design and configuration specialists that also fully understand clinical data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH). Perhaps your current role has only focused on configuration or data management experience, here at Veeva, we realize the importance of both in one role.
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) for this employment position.
What You'll Do
- Review and finalize all project specifications applying industry and Veeva best practices
- Engage with existing Vault CDMS customers or potential customers in pre-sales phases on their data management challenges and determine how Vault CDMS can alleviate current obstacles and support services pre-sales activities including review of customer requirements and scoping
- Participate in Vault CDMS Product team discussions to convey data management activities, challenges, and end- user expectations.
- Support the requirements gathering and specification creation process for all study integrations and configure Veeva products during development and support developers and testers during the project lifecycle
- Conduct on-site or remote user acceptance testing with the customer including coordination of all feedback, resolution of issues and acceptance of the study and support go-live activities for the study to ensure a smooth transition of the study to the customer
- Act as the customers trusted advisor to ensure that the study trial design is configured in such a way that it meets the customer's goals and offers the full benefits of Veevas CDMS application
- Assure process compliance with all regulatory and Veeva procedural requirements
- Participate and contribute to process product or best practices initiatives and share data management experiences and educate fellow Vault CDMS team members on CDM standards and guidelines.
- 5+ years of experience in end to end data management related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
- 5+ years of direct experience working with EDC clinical software solutions in clinical operations, and/or trial management in a project management/consultant role and a strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).
- Experience in working with customers to build libraries and define data standards for use in their clinical studies, expert on life sciences compliance and computer systems validation requirements
- Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
- Experience in a customer-facing role, preferably with a software professional services organization or consulting background with demonstrated success with customers during project assessment, planning, development, training, and implementation.
- Ability and willingness to roll up your sleeves to implement a clinical solution and have a logical approach to problem-solving
- Excellent verbal and written communication, interpersonal, and presentation skills
- Ability to travel 25-30% (may include international)
Nice to Have
- Hands on data management experience.
- 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
- Familiarity with CDISC, ODM and other data management industry standards
- SaaS/Cloud experience in the delivery of clinical trials
- Enterprise experience and knowledge transfer for running clinical trials with EDC
- Experience with training for clinical sites and at investigator meetings
- Consulting experience
Perks & Benefits
- Flexible PTO
- Allocations for continuous learning & development
- Health & wellness programs
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 currently reside in the State of Colorado, relocation would be required for this position.