Associate, Study Management III

• Plan, execute, and manage one or more Phase 0–4 global clinical trials
• Provide study-level oversight and leadership from inception through closure
• Support strategic leadership of cross-functional teams through stakeholder engagement and influence
• Develop strategies, facilitate meetings, and document study-level activities
• Manage external vendors, including RFPs, selection, scopes of work, deliverables, and risks
• Lead global recruitment strategy, feasibility, recruitment, retention, and mitigation planning
• Lead cross-functional, vendor, and investigator meetings and provide study-status updates
• Ensure inspection readiness and participate in related activities
• Identify, mitigate, escalate, and manage study risks
• Co-develop and manage protocols, regulatory submissions, informed consent, budgets, agreements, reports, training materials, newsletters, and presentations
• Manage CTMS and eTMF for compliance, inspection readiness, trend analysis, and timelines
• Support EDC, IRT, and ePRO design reviews, user acceptance testing, plans, risk indicators, access, queries, and oversight
• Manage investigational product and 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
• Competent in standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experienced user of 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 in a global setting
• Proficient in business/technical English-language, oral and written
• Proactive, collaborative mindset
• Ability to work independently in a fast-paced global team environment
• Preferred: exposure to study initiation through completion activities and global study exposure

• Full-time employment
• Remote work option / may be located virtually
• Equal opportunity employment
• Opportunity to work on innovative medicines and solutions impacting serious health issues
• Exposure to global clinical trials and cross-functional collaboration
• Mentorship and subject matter expert opportunities