Cloudious
3 to 5 Year(s)
Minimum of 5 years of experience as a product manager3 to 5 years working on clinical studiesExperience with EDC systems is a plusExperience with 21 CFR Part 11 and Google Cloud PlatformExperience MHRA and other regulatory agenciesExperience with electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO)Experience with study protocol analysis, including requirements extraction for COA builds and creation / implementation of study design plansDemonstrated success defining and launching productsBachelor’s degree (MBA is a plus)Excellent written and verbal communication skillsExcellent business and technical stakeholder management skillsExperience in software product definition and development, especially on mobile/cloud applicationsProven ability to influence cross-functional teams without formal authorityExcellent teamwork skillsRESPONSIBILITIESTo facilitate the definition and prioritization of requirements, systems enhancements, and process improvement from user communities by leading systems management teams and regularly communicating with key stakeholders for the product area.To partner with project managers to ensure that requirements are fulfilled, and the launch of the product or enhancement is successful.To participate in and develops stakeholder communications, user training, and product demonstrations.To develop product materials and collateral to increase internal and external adoption of systems and processes.Ability to draft, review, finalize user requirement and functional specificationsTo support/understand the overall agile SDLC, Testing, and validation processesTo coordinate resolution & risk mitigation of all ePRO / eCOA-related issues and end-of-study vendor deliverablesTo write/update SOPs and develop a library of ePRO data capture and reporting standards, as neededAs required, to work with Vendor PMs to maintain timelines and determine external potential risks