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Senior Consultant - CDMS Services

  • Job
    Full-time
    Senior Level
  • Consulting
    Research & Development
  • Madrid
    Remote

AI generated summary

  • You need 5+ years in EDC data management, experience with clinical protocols, form design, data standards, customer-facing roles, and a proven track record of meeting deadlines. Travel up to 25%.
  • You will gather requirements, design clinical trials with Vault CDMS, author specifications, train users, lead testing sessions, manage project risks, and implement configuration changes post go-live.

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)

Responsibilities

  • Lead requirements-gathering sessions to understand 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, create specifications, and implement a study design with the Vault CDMS application
  • 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
  • Train and mentor customers and clinical sites who are working with the Vault CDMS application or are new to clinical trials
  • 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

FAQs

Do we support remote work?

Yes, this position can be done remotely within the EU or in one of our EU offices.

What is the main responsibility of a Senior Consultant in CDMS Services?

The Senior Consultant will act as the customer's trusted advisor, ensuring that the study trial design is configured to meet their goals and offers the full benefits of Veeva's CDMS application.

What qualifications are required for this position?

Candidates should have 5+ years of experience in end-to-end data management-related activities in EDC, experience interpreting clinical protocols, and a strong understanding of data management standards and guidelines.

Is travel required for this role?

Yes, the position requires the ability to travel up to 25%, which may include international travel.

What kind of experience is preferred for this role?

Preferred experience includes hands-on data management, working with system integrators for clinical technologies, and fluency in one or more languages such as German, French, Spanish, or Italian.

What is the company's stance on diversity and inclusion?

Veeva is committed to fostering a culture of inclusion and growing a diverse workforce, valuing people for their unique contributions.

Are there any specific practices that the Senior Consultant must adhere to?

Yes, the Senior Consultant must adhere to Good Clinical Data Management Practices and Veeva standards to optimize value.

What does the "Work Anywhere" policy entail?

The "Work Anywhere" policy allows employees to work in the office or at home on any given day, focusing on getting work done in the environment that works best for them.

What educational background is beneficial for this role?

A life science, computer science, or related degree is beneficial for this position.

Are there opportunities for training and mentorship in this role?

Yes, the Senior Consultant will train and mentor customers and clinical sites who are new to the Vault CDMS application or clinical trials.

The Industry Cloud for Life Sciences.

Technology
Industry
1001-5000
Employees
2007
Founded Year

Mission & Purpose

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 875 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Canada, Europe, Asia, and Latin America.