Associate, Study Management III (Remote)

Role Summary

Associate, Study Management III (Remote) role focused on planning, executing, and managing global clinical trials within a centralized study management team. Independent contributor in a cross-functional, global environment, ensuring study quality, timeliness, and budget alignment under guidance from the Study Project Manager and SMA Manager. Global role, may be located virtually.

Responsibilities

• Study-level oversight and leadership of one or more global trials in a cross-functional environment from inception through closure, connecting functional and strategic work across the global study.
• Support the Study Project Manager in strategic leadership of the cross-functional team, including strategy development, meeting facilitation, and timely documentation at the study level to drive timely execution of clinical trials.
• Vendor management, including RFP/initiation, selection, scope of work development and review, deliverable oversight, and risk management for external vendors (e.g., central lab, recruitment, imaging).
• Recruitment management, including review of data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning globally from feasibility to recruitment and retention.
• Leadership of assigned meetings (internal, vendor, and/or investigator), providing regular updates on study status, agenda development, minutes curation and filing; ensure inspection readiness.
• Risk identification, mitigation, and management, including issue review, escalation, and management to support trend analysis and risk prevention.
• Co-development and management of study materials (protocols, regulatory submissions, PRO measures, study execution plan, informed consent, site budgets/agreements, clinical study report, training materials, newsletters, presentations) and CTMS/eTMF management to ensure compliance and inspection readiness, support trend analyses and timelines.
• EDC/IRT/ePRO involvement, including design spec review, user acceptance testing, plans development/review, risk indicators, and system management (access support, query resolution, oversight); management of investigational product and study supplies.
• Provide engaging training to stakeholders as needed; support global submission strategies and process improvement initiatives; serve as SME or mentor.

Qualifications

• Bachelor’s Degree or equivalent required
• At least 4 years of progressive Pharma/clinical research experience with core and technical competencies
• Competent in standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experience with EDC, IRT, CTMS, and eTMF
• Strong analytical and critical thinking to evaluate complex issues and drive decision making to accelerate timelines
• Excellent organizational and time management skills with attention to detail
• Exceptional interpersonal skills; clear and persuasive communication in a global setting; proficient in business/technical English
• Proactive, collaborative mindset; ability to work independently in a fast-paced global team
• Preferred: Global study exposure or experience from initiation through completion

Skills

• Clinical study leadership
• Cross-functional coordination
• Vendor management
• Recruitment strategy and execution
• Meeting leadership and documentation
• Risk management and issue escalation
• Documentation management (protocols, CSRs, ICFs, UDAs)
• CTMS/eTMF/EDC/IRT/ePRO systems proficiency
• Training and stakeholder engagement

Education

• Bachelor’s Degree or equivalent required