Consultant - CDMS Services

Summary

Join Veeva Systems, a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As a Work Anywhere company, we support your flexibility to work from home or in the office.

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

Responsibilities

• 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
• 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
• 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

Preferred Qualifications

• 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

Benefits

• Allocations for continuous learning & development
• Health & wellness programs