Consultant - CDMS Services (Remote)
Veeva Systems
- London
- Permanent
- Full-time
- 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
- Support developers and testers during the project lifecycle
- Support the requirements gathering and specification creation process for all study integrations
- 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 go-live activities for the study to ensure a smooth transition of the study to the customer
- Review requirements as part of the change management process and update specifications and configurations as necessary with associated scoping activities
- Act as the customer's 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
- Ensure customer success from beginning to end of the project life cycle
- Assure process compliance with all regulatory and Veeva procedural requirements
- Participate and contribute to process product or best practices initiatives
- 2+ years' experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
- 2+ years' direct 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 process preferred (pharmaceutical, biotech, medical device companies, CRO's, and academic & public health organizations)
- Experience in a customer-facing role, preferably with a software professional services organization or consulting background, is preferred
- Working Knowledge of Clinical Trial processes across pharmaceuticals, device, and/or biotech sectors, specifically as they relate to design, document, and data collection
- Ability to quickly understand business requirements
- Proven ability to work independently in a dynamic environment but also as part of a team
- Logical approach to problem solving
- Ability to manage multiple tasks and project deliverables
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
- Demonstrated success with customers during project assessment, planning, development, training, and implementation
- Excellent verbal and written communication, interpersonal, and presentation skills
- Ability to travel 20-25% (may include international)
- 4-year college degree required
- 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
- Allocations for continuous learning & development
- Health & wellness programs