Overview
Who_we_are_(PRA’s_SSD_Business_Unit) Over 470 PRA Biometrics resources currently in FTE Programs across 12 global clients Resources located in North America, South America, China and Europe Roles include embedded, dedicated leadership structure all levels of Data Managers, Stats Programmers, Biostatistics, IVRS, ePRO, Medical Coding Several teams are remote, others partially based in PRA’s Philadelphia- area office, others at Sponsor sites, and global PRA facilities Management is almost always grown from within, with a PRA manager in place for every team Teams range in size from 1 to 200 resources Several relationships have been established for 5, 10, and 15 years Our_motto: One client One team One set of processes to learn Why_join_SSD_Biometrics? PTO policy is very competitive Employee Stock Purchase Plan Significant return rate of PRA ex-employees Opportunities to get involved in client initiatives, process improvements, investigator meetings, training, mentoring See the results of your work through direct discussions, meetings, town halls and team-building events with client leadership High retention of team members and management means stable_teams_and positive_program_culture We are hiring for an experienced 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. Responsibilities Manage translation process and timelines with vendors Kickoff ePRO development Draft/finalize user requirement specifications Participate and execution of 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 standard operating procedures, 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. Qualifications Required: 3 to 5 years of experience working on clinical studies electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient- Reported Outcome (ePRO) experience 2 years of project management and vendor management experience experience with eCOA / ePRO start/set-up, conduct, and closeout Preferred: InForm EDC experience MS Project experience Experience managing regulations and requirements across multiple countries System design or study design experience PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. Show moreShow less