Clinical Data Management Specialist

2 months ago

London, Greater London, United Kingdom Veeva Systems, Inc. Full time

About the Role

Veeva Systems, Inc. is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. Our core values are Do the Right Thing, Customer Success, Employee Success, and Speed. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

We are committed to transforming the life sciences industry, making a positive impact on our customers, employees, and communities. Our Veeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is managed in the industry. Vault CDMS combines Electronic Data Capture (EDC), coding, data cleaning, and reporting into one application, enabling research teams to make faster and more informed decisions.

As a key member of our CDMS Professional Services team, the Senior Consultant will be at the forefront of our mission to transform the life sciences industry. You will act as the customer's trusted advisor to ensure that the study trial design is configured in such a way that it meets their goals and offers the full benefits of Veeva's CDMS application.

This is a Work Anywhere position - you can choose to work remotely in the EU, or in one of our EU offices.

Key Responsibilities

  • Lead requirements-gathering sessions to understand customers' data management needs and challenges.
  • Adhere to Good Clinical Data Management Practices and Veeva standards to optimize value.
  • Author all specification documents used by team members and configure Veeva products during the development phase of the project.
  • Support the requirements gathering and specification creation process for all study integrations.
  • Lead customer requirement and testing sessions.
  • Notify project management of project risks and develop contingency plans as necessary.
  • Deliver post go-live configuration changes.

Requirements

  • 5+ years experience in end-to-end data management-related activities in EDC (database design and configuration, data collection, data analysis, query resolution, datasets, statistical reporting).
  • Experience in interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation.
  • Experience in designing forms and rules in EDC, as well as understanding how data is managed, cleaned, and reported.
  • Strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).
  • Experience in a customer-facing role, preferably with a software professional services or consulting organization.
  • Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results.
  • Ability to travel up to 25% (may include international).

Nice to Have

  • Hands-on data management experience.
  • Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies.
  • Experience with defining data standards and libraries.
  • Life Science, computer science, or related degree.
  • Experience with training for clinical sites and at investigator meetings.
  • Fluency in one or more of the following languages: German, French, Spanish, Italian.

Veeva Systems, Inc. is an equal opportunity employer, committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability, and life experience shape us all into unique individuals. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us.

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