Study Management Associate III

• Execute and manage one or more Phase 0–4 global clinical trials
• Plan, execute, and manage studies under the guidance of the Study Project Manager and SMA Manager
• Provide study-level oversight and leadership from inception through closure
• Support cross-functional team strategic leadership through stakeholder engagement, strategy development, meeting facilitation, and documentation
• Manage external vendors, including RFPs, selection, scopes of work, deliverables, and risk management
• Lead global recruitment management, strategy development, and mitigation planning
• Lead cross-functional, vendor, and investigator meetings; provide regular study-status updates
• Ensure inspection readiness and participate in related activities
• Identify, mitigate, and manage risks, including issue review, escalation, and trend analysis
• Co-develop and manage study materials, protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, budgets and agreements, clinical study reports, training materials, newsletters, and presentations
• Manage CTMS and eTMF for compliance, inspection readiness, trend analysis, and timelines
• Support EDC, IRT, and ePRO design, user acceptance testing, plans, risk indicators, access, query resolution, and oversight
• Manage investigational product and associated study supplies
• Provide stakeholder training
• Support global submission strategies
• Support process improvement initiatives or serve as a subject matter expert and/or mentor

• Bachelor’s Degree or OUS equivalent required
• At least 4 years of progressive Pharma-related/clinical research-related experience
• High level of core and technical competencies
• Competence in standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experience using EDC, IRT, CTMS, and eTMF
• Strong analytical and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• Exceptional interpersonal and communication skills
• Proficient in business/technical English-language, oral and written
• Proactive, collaborative mindset
• Ability to work independently in a fast-paced global team environment
• Exposure to study initiation through completion activities preferred
• Global study exposure preferred

• Paid time off (vacation, holidays, sick)
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• Eligibility to participate in short-term incentive programs