Remote Consultant - CDMS Services

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Veeva Systems

📍Remote - Spain

Job highlights

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

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