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Veeva Systems

Builds cloud software for life sciences

Senior Consultant - Clinical Data Programming

Implementation & Technical Account ManagementConfirmed live in the last 24 hours
Full-timeMassachusetts, USA

About the Job

Requirements

  • At least 5 years of experience working with electronic data capture (EDC) clinical software solutions in end-to-end data management activities, including database design, data collection, data analysis, query resolution, datasets, and statistical reporting.
  • Working knowledge of clinical trial processes, specifically data collection and review.
  • Prior experience in programming languages such as SAS, R, JSON, Python, and SQL, with the ability to learn new programming languages, including a SQL-based language.
  • Expertise in life sciences industry and clinical trial processes in relation to design, documentation, and data collection, with demonstrated success during project assessment, planning, development, training, and implementation with customers.
  • Experience in a customer-facing role, preferably with a software professional services or consulting organization.
  • Ability to work independently and collaboratively in a dynamic, fast-moving environment and meet project timelines with quality results.
  • Ability to travel up to 10%, which may include international travel.

Responsibilities

  • Act as a trusted advisor to customers and clinical sites, ensuring study trial design is configured to meet customer goals and realizing the benefits of the CDMS application while providing training and mentorship.
  • Consult with customers to review and understand clinical protocol requirements and project specifications, applying industry and Veeva best practices.
  • Drive database development activities according to implementation project plans, working with sponsor, CRO, and external vendor teams.
  • Collaborate with clinical data providers, including central laboratories, ECG, eCOA, and IRT providers, to receive data and configure transfers according to requirements.
  • Configure forms, rules, and other study items in Veeva Vault CDMS during development, and develop custom listings using a SQL-based language based on customer data-cleaning requirements.
  • Conduct on-site or remote user acceptance testing with customers, coordinate feedback and issue resolution, and obtain study acceptance.
  • Support requirements gathering and specification creation for study integrations and go-live activities to ensure a smooth transition to the customer.
  • Communicate potential risks and contingency plans with project management to ensure compliance with regulatory and Veeva procedural requirements.
  • Contribute to process, product, or best-practice initiatives and support developers and testers during the project lifecycle.
  • Participate in Vault CDMS product team discussions to convey data management activities, challenges, and end-user expectations.
  • Configure and support data ingestions (imports) into Veeva DQS.

Desired Qualifications

  • Working understanding of data management standards and guidelines, including GCDMP, CDISC, SDTMIG, CDASH, and ADaM.
  • Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies.
  • Integration or programming experience with REST-based APIs.
  • Experience interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation.
  • Experience with Veeva applications.
  • Locality to a major life sciences customer hub.
  • A degree in Life Science, Computer Science, or a related field.

About the Company

Veeva Systems

Builds cloud software for life sciences

Veeva Systems builds cloud software and data products for pharmaceutical, biotechnology and other life sciences companies. Its applications support clinical trials, regulatory submissions, quality management, drug safety and commercial teams that work with healthcare professionals. Teams use the software to organize documents, track records and coordinate regulated work across departments on Veeva's Vault platform. Veeva earns revenue from subscriptions to its software and data products, alongside implementation, consulting and other professional services. Founded in 2007, Veeva Systems is headquartered in Pleasanton, California, United States.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Pleasanton, CA
Founded
2007

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