Bachelor's degree or equivalent combination of education/experience in science or health-related field (Advanced degree preferred) Minimum of 7 years of clinical research experience or proven competencies Minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS Proven communication and interpersonal skills Proven organizational skills, attention to detail, and customer service demeanor Knowledge of ICH-GCP and relevant SOPs Proven knowledge of project management techniques and tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management, and change management Proven experience in strategic planning, risk management, and change management High level of integrity Ability to lead and inspire excellence within a study team Ability to create an environment of ownership Results oriented, accountable, motivated, and flexible Proven time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills Proven presentation, verbal, and written communication skills Good understanding of project management software In-depth proven experience in pharmaceutical and/or device research Preferred: experience with oncology & cell and/or gene therapy