Senior Consultant - CDMS Services (Remote)

Expiring today

Location
Work Anywhere - United Kingdom
Salary
Competitive
Posted
17 Sep 2021
Closes
17 Oct 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

The Role

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. Gone are the days of complex integrations that limit clinical data availability as Vault CDMS enables research teams to make faster and more informed decisions.

Veeva Systems is looking for Senior Consultants who have deep data management expertise and are experienced in helping customers to optimize the use of EDC in running their clinical trials. We’re looking for EDC design and configuration specialists (experienced in eCRF’s, Edit Checks) with solid understanding of clinical data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH). Designing forms and rules in EDC, as well as understanding how data is managed, cleaned and reported are equally important.  

As a key member of our CDMS Professional Services team, the Senior 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.  
  • Understanding our customers’ clinical trial, protocol requirements to implement a study design with the Vault CDMS application adhering 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.
  • Train and mentor customers and clinical sites who are working with the Vault CDMS application or are new to clinical trials.

Opportunities are available within the EU for this role; this is a remote position. There is no work location requirement as long as you are close to an airport and able to meet travel requirements. Qualified EU based candidates are encouraged to apply, Veeva Systems does not anticipate providing sponsorship for employment visa status for this employment position.

What You'll Do

  • Review and finalize all project specifications applying industry and Veeva best practices,
  • Configure Veeva products during development,
  • Support the requirements gathering and specification creation process for all study integrations,
  • Lead customer requirement and testing sessions,
  • Act as the customers 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,
  • Deliver post go-live configuration changes.

Requirements

  • 5+ years experience in end-to-end data management related activities in EDC (database design, data collection, data analysis, query resolution, datasets, statistical reporting),
  • Strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH),
  • Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation,
  • Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred,
  • Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team,
  • Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results,
  • Excellent verbal and written communication, interpersonal, and presentation skills,
  • 4-year college degree required,
  • Ability to travel 25-30% (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,
  • SaaS/Cloud experience in the delivery of clinical trials,
  • Experience with training for clinical sites and at investigator meetings,
  • Consulting experience,
  • Fluency in one or more of the following languages: German, French, Spanish, Italian.

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