What You’ll Do

• 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
• Configure forms, rules, and other study items with Veeva Vault CDMS product during development
• 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
• 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
• 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

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)
• 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 20-25% (may include international)

Nice to Have

• Working understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH)
• 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
• Life Science, computer science, or related degree

Perks & Benefits

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

Compensation

• Base pay: $80,000 - $200,000
• The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.