Senior Consultant, CDMS Services (Vault EDC)
Veeva Systems
Seoul, South Korea
5 일 전

At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries.

Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives.

Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.

Veeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is managed in the industry. Vault CDMS combines EDC, coding, Data Cleaning, and Reporting into one application.

The days of complex integrations limiting clinical data availability are gone; now research teams can make faster and more informed decisions.

As a key member of our CDMS Professional Services team, the Senior Consultant will be responsible for four main things as part of a Clinical Study build :

  • Review study protocol requirements and implement a design adhering to Good Clinical Data Management Practices and Veeva standards to optimize value
  • Author all specification documents used by team members
  • Configure the study design during the development phase of the project
  • Train and mentor customers who are working with the Vault CDMS application or are new to clinical trials.
  • What You'll Do

  • Work with customers to review and understand clinical protocol requirements, prepare and review all project specifications applying industry and Veeva best practices
  • 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
  • Configure Veeva EDC during the development phase; support developers and testers during the project lifecycle
  • Support the requirements gathering and specifications related to 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
  • Apart from your involvement in Projects, you will participate in discussions with our Product team to convey challenges or requirements specific to your market.
  • You will also have an opportunity to share data management experiences and educate fellow Vault CDMS team members on CDM standards and guidelines.

    Requirements

  • 5+ years of experience working with EDC clinical software and / or clinical data management
  • Experience with trial design for clinical trials
  • Good understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH)Demonstrated consulting experience (internal or external)
  • Ability and willingness to roll up your sleeves to implement a clinical solution
  • Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
  • Fluent in English and Korean
  • Excellent verbal and written communication, interpersonal, and presentation skills
  • Nice to Have

  • Hands-on data management experience
  • Active CDM society memberships (ie, CCDM®)
  • Experience working with Veeva Vault EDC, Oracle InForm, Medidata Rave, CRScube, Medrio
  • Experience working with clinical technologies such as CTMS, eTMF, IVRS, medical coding, eSource
  • SaaS / Cloud experience in the delivery of clinical trials
  • Experience with training for clinical sites and at investigator meetings
  • Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

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