Remote Senior Consultant - CDMS Services (EDC)

Summary

Join us in transforming the life sciences industry as a Work Anywhere company, committed to making a positive impact on its customers, employees, and communities. We're looking for a professional to work with customers to review and understand clinical protocol requirements and prepare project specifications applying industry and Veeva best practices.

Requirements

• 2+ years’ experience in IT industry experience
• 2+ years’ experience working with software solutions
• Experience in a customer-facing role, preferably with a software professional services organization or consulting background, is preferred
• Proven ability to work independently in a dynamic environment but also 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
• Ability to travel 20-25% (may include international)

Responsibilities

• Work with customers to review and understand clinical protocol requirements
• Prepare, review, and finalize all project specifications applying industry and Veeva best practices
• Participate in Product team discussions to convey customer activities, challenges, and end-user expectations
• Configure systems and support the customer for project success
• 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 for the study to ensure a smooth transition of the study to the customer
• Act as the customer's trusted advisor to 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 Clinical Data application
• Notify project management of project risks and 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

Preferred Qualifications

• Experience in interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation
• 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
• 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
• Experience with training for clinical sites and at investigator meetings
• Consulting experience