location_onLondon, UK
watch_later Posted: Oct 01, 2024
Skills Required
Nice To Have skills
Job Description
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.
As a key member of our CDMS Professional Services team, the Consultant will be at the forefront of our mission and responsible for four main things:
Understanding customers’ data management needs and challenges, offer guidance and direction to ensure that the clinical trial is designed with the deliverable in view.
Understand our customers’ clinical trial protocol requirements to implement a study design with the Vault.
CDMS application adheres to Good Clinical Data Management Practices and Veeva standards to optimize value.
Responsible for authoring all specification documents used by team members and configuring the study design during the development phase of the project inclusive of forms, rules, and study configuration.
What You'll Do
- 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
Requirements
- 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
Nice to Have
- 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 programs
