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 Consultants who have life sciences software configuration experience specifically in helping customers optimize the use of EDC in running their clinical trials. EDC design and configuration experience and a working understanding of how data is managed, cleaned and reported.

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.

Work with customers to review and understand clinical protocol requirements and prepare, review and finalize all project specifications applying industry and Veeva best practices

Participate in Vault CDMS Product team discussions to convey data management activities, challenges and end user expectations.

Configure forms, rules and other study items with Veeva Vault CDMS product during development

Conduct on-site or remote user acceptance testing with the customer including coordination of all feedback, resolution of issues and acceptance of the study

Support requirements gathering and specification creation process for all study integrations and 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 Veeva’s CDMS application

Notify project management of project risks and develop contingency plans as necessary and assure process compliance with all regulatory and Veeva procedural requirements

Participate and contribute to process product, or best practices initiatives and support developers and testers during the project lifecycle

2+ years’ experience in end to end data management related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)

2+ years’ experience working with EDC clinical software solutions in clinical operations, and/or trial management in a project management/consultant role

Life sciences industry experience and knowledge of clinical trial processes (pharmaceutical, biotech, medical device companies, CRO’s and academic public health organizations) as they relate to design, document, and data collection - demonstrated success with customers during project assessment, planning, development, training and implementation.

Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred

Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team

Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results

Excellent verbal and written communication, interpersonal, and presentation skills

Ability to travel 20-25% (may include international)

Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation

Working understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).

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

Experience with training for clinical sites and at investigator meetings

Consulting experience

Perks Benefits

Allocations for continuous learning development

Health wellness program