Daniel Mcnelis Email & Phone Number

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Seventeen years of experience with Process, Team, and Project Management of Clinical Trial software translation for an industry leader supporting 70% of all Food and Drug Administration (FDA) approvals. Served as departmental lead to oversee development of a tool that cut translation timelines by 30%.• Client-facing Project Management of eCOA device screenshot and supplementary material translations for software used in Electronic Clinical Outcome Assessments (eCOA), including… Show more Seventeen years of experience with Process, Team, and Project Management of Clinical Trial software translation for an industry leader supporting 70% of all Food and Drug Administration (FDA) approvals. Served as departmental lead to oversee development of a tool that cut translation timelines by 30%.• Client-facing Project Management of eCOA device screenshot and supplementary material translations for software used in Electronic Clinical Outcome Assessments (eCOA), including Electronic Patient-Reported Outcomes (ePRO).• Conducted triage, escalation, and issue resolution for clients and external translation vendors.• Assessed and managed assignment of client-requested scope or content changes to software in ongoing clinical trials.• Performed requirement scoping, evaluation, and training for departmental tool design and implementation, acting as Subject Matter Expert (SME) for a team of 40+ Project Managers.• Managed international team of Translations Project Managers in multiple locations and time zones. Show less

Pittsburgh, Pa

Process expert responsible for creation, analysis, and adaptation of new business procedures and departmental training.• Led, implemented, and supported all Operations Readiness initiatives as new devices, software enhancements, or procedures are introduced, resulting in 100% departmental compliance. • Created and maintained departmental Standard Operations Procedures and Work instructions.• Ordered, tracked, and maintained smartphone and tablet devices for… Show more Process expert responsible for creation, analysis, and adaptation of new business procedures and departmental training.• Led, implemented, and supported all Operations Readiness initiatives as new devices, software enhancements, or procedures are introduced, resulting in 100% departmental compliance. • Created and maintained departmental Standard Operations Procedures and Work instructions.• Ordered, tracked, and maintained smartphone and tablet devices for department.• Managed Standardized Library of translations for common diaries and questionnaires in clinical trial studies. Show less

Pittsburgh, Pa

Led team of Translations Project Managers for eCOA and ePRO studies and provided training for new software tools and processes.• Managed Library of core software text translations in 100+ languages.• Deadline-driven Project Management and support supervision. • Design and presentation of training materials. • Resource planning and administration.• Software defect investigation and resolution. • Vendor management and correspondence.

Master Of Arts (M.A.), Adult Education And Communications Technology, 4.0 Gpa

Activities and Societies: WIUP FM Radio

Bachelor'S Degree, Marketing/Journalism