Who are we? We Are PRA. We are 17,000+ employees strong, operating in more than 90+ countries. PRA is committed to saving lives and constantly striving to be the best at what we do. Our impact is real, and we see it every day. We help get life-saving drugs into the hands of those who need them most.
We are currently hiring for a senior-level Global ePRO / eCOA Project Manager. This is an excellent opportunity for career development, as our company continues to grow. This particular role will be part of a dedicated Data Management team and support an embedded client, a global Pharmaceutical company.
Manage translation process and timelines with vendors
Kickoff ePRO development
Draft/finalize user requirement specifications
Execute UAT scripts / change requests
Establish Project Plan via Microsoft Project
Manage ePRO project schedule
Coordinate resolution & risk mitigation of all ePRO / eCOA-related issues and end-of-study vendor deliverables
Write / update SOPs and develop a library of ePRO data capture and reporting standards, as needed
Provide support to the IVRS team, as needed
Work with Vendor PMs to maintain timelines and determine resources
Ensure sites/patients have device inventory
Manage new requirements / regulations across multiple countries
Support ongoing maintenance / database lock activities
Serve as ePRO Subject Matter Expert
Manage the decommissioning process with the eCOA vendor, at study close-out.
3 to 5+ years working on clinical studies
electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO) experience
2 to 3+ years of project management and vendor management
Study protocol analysis experience, including requirements extraction for COA builds and creation / implementation of study design plans
Translation knowledge & experience, including experience working with translation teams/vendors
Execution of UAT Scripts and/or Change Requests
Solid study start-up experience, including having led cross-functional kickoff meetings for EDC, ePRO and/or eCOA activities
Study close-out experience, including: international device shipping (returns), archiving, risk mitigation, and management of decommissioning activities with eCOA vendor
Global management of regulations and requirements
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA Health Sciences