Study Delivery Senior Associate

• Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools
• Coordinate logistics for investigator meetings, trial events, and site communications
• Manage assigned start-up activities, including system setup, access management, and document readiness
• Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators
• Lead delivery of assigned risk and quality management activities
• Track and report study progress, coordinating with Study team and vendors to resolve operational issues
• Deliver assigned components of global recruitment and retention strategies
• Manage Study Training system activities and oversight
• Build and maintain effective relationships with internal study team members, vendors and investigator sites
• Act as a point of contact for routine study updates
• Identify, prioritize, and escalate risks effectively
• Lead vendors and supplier set-up
• Maintain and monitor clinical trial systems
• Support data collection oversight, including query resolution and reconciliation activities
• Manage trial documentation
• Contribute to best practice development, knowledge-sharing and process improvement
• Proactively identify and highlight opportunities to streamline / automate activities
• Support Audit/Inspections including Corrective and Preventive Actions (CAPA) processes

• Master’s degree
• Bachelor’s degree and 2 years of clinical execution experience
• Associate’s degree and 6 years of clinical execution experience
• High school diploma / GED and 8 years of clinical execution experience
• 3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience working on global clinical trials
• Strong collaborative and effective communication skills within a team environment
• Understands importance of accuracy in documentation, data tracking, and compliance checks
• Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
• Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
• Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
• Experience with overseeing vendors and suppliers
• Experience executing risk-based site monitoring, Audit and Inspections Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness
• Cultural sensitivity and collaboration across global teams
• Ability to recognize, highlight and resolve issues
• Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
• Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions

Reasonable accommodation for individuals with disabilities