Senior Consultant - Clinical Data Programming

Summary

Join Veeva Systems, a leading life sciences industry cloud company, as a Senior Consultant. You will act as a trusted advisor to customers, ensuring their clinical trial designs are optimally configured within Veeva's CDMS application. Responsibilities include working with customers to understand clinical protocol requirements, driving database development, collaborating with data providers, configuring study items, conducting user acceptance testing, and supporting requirements gathering. This remote, full-time role requires extensive experience with EDC clinical software and programming languages like SQL. The ideal candidate will possess strong communication and collaboration skills and a proven ability to meet project timelines. Veeva offers a comprehensive benefits package, including medical, dental, vision, flexible PTO, retirement programs, and a charitable giving program.

Requirements

• 5+ years of experience working with EDC clinical software solutions in end-to-end data management related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
• Working knowledge of clinical trial processes, specifically as they relate to data collection and review
• Prior experience in programming languages such as (SAS, R, JSON, Python, SQL) with the ability to learn new programming languages (SQL-based language)
• Life sciences industry and clinical trial processes (pharmaceutical, biotech, medical device companies, CRO’s, and academic & public health organizations) expertise 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
• Proven ability to work independently and collaboratively in a dynamic, fast-moving environment and meeting project timelines with quality results
• Excellent verbal and written communication, interpersonal, and presentation skills
• Ability to travel up to 10% (may include international)

Responsibilities

• Act as the customer and clinical site trusted advisor to ensure that the study trial design is configured to meet the customer’s goals and offer full benefits of Veeva’s CDMS application while providing training and mentorship
• Work and consult with customers to review and understand clinical protocol requirements and all project specifications, applying industry and Veeva best practices
• Drive database development activities per implementation project plan by working with various members of the sponsor, CRO, and other external vendor teams
• Collaborate with clinical data providers (Central Laboratories, ECG, eCOA, IRT, etc.) to receive data and configure transfers based on requirements
• Configure forms, rules, and other study items with Veeva Vault CDMS product during development and develop custom listings based on customer data cleaning requirements using SQL-based language
• 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 requirements gathering and specification creation process for all study integrations and go-live activities to ensure a smooth transition of the study to the customer
• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Veeva procedural requirements
• Participate and contribute to process product or best practices 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 CDB

Preferred Qualifications

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

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program