Job Description :
Location: Raleigh, North Carolina
Duration: 12 months

Experience in product releases. application development nor Clinical Trials design.
· To 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 specifications
· To support/understand the overall agile SDLC, Testing, and validation processes
· To coordinate resolution & risk mitigation of all ePRO / eCOA-related issues and end-of-study vendor deliverables
· To write/update SOPs and develop a library of ePRO data capture and reporting standards, as needed
· As required, to work with Vendor PMs to maintain timelines and determine external potential risks
· Minimum of 5 years of experience as a product manager
· 3 to 5 years working on clinical studies
· Experience with EDC systems is a plus
· Experience with 21 CFR Part 11 and GcP
· Experience MHRA and other regulatory agencies
· Experience 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 plans
· Demonstrated success defining and launching products
· Bachelor’s degree (MBA is a plus)
· Excellent written and verbal communication skills
· Excellent business and technical stakeholder management skills
· Experience in software product definition and development, especially on mobile/cloud applications
· Proven ability to influence cross-functional teams without formal authority
· Excellent teamwork skills