Veeva Product Manager

Responsibilities

• Work with customers to review and understand clinical protocol requirements and prepare, review, and finalize all project specifications applying industry and Veeva best practices.
• Participate in Vault CDMS Product team discussions to convey data management activities, challenges, and end-user expectations.
• 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.
• Notify project management of project risks, develop contingency plans as necessary, and assure 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.

Required Experience

• 6+ years of hands-on product management experience.
• 2+ years of Veeva software product management experience.
• 2+ years experience in end-to-end data management-related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting).
• 2+ years experience working with EDC clinical software solutions in clinical operations and/or trial management in a project management/consultant role.
• Life sciences industry experience and knowledge of clinical trial processes (pharmaceutical, biotech, medical device companies, CROs, and academic & public health organizations) as they relate to design, document, and data collection - demonstrated success with customers during project assessment, planning, development, training, and implementation.
• Experience in a customer-facing role, preferably with a software professional services organization or consulting background.
• Proven ability to work independently in a dynamic, fast-moving environment and 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.

Preferred Experience

• Experience interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation.
• Understanding 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.
• Life Science, computer science, or related degree.
• Familiarity with CDISC, ODM, and other data management industry standards.
• SaaS/Cloud experience in the delivery of clinical trials.