Study Delivery Associate

• Support the setup and maintenance of study-level trackers, dashboards and timelines
• Communicate study progress, timelines and deliverables to the Study Delivery Manager
• Assist with tracking and following up on study actions, including risk mitigation actions
• Assist with the preparation and record keeping of risk & quality reviews
• Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements
• Assist with trial-related events, global site communications, and logistics for investigator meetings
• Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness
• Support vendor relationships and site engagement strategies
• Manage shipment, reconciliation and analysis of biological samples
• Coordinate investigational product logistics, ensuring compliance with reconciliation processes
• Maintain clinical trial systems (e.g., CTMS, study training), ensuring timely and accurate data entry
• Support system access requests and access management
• Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides
• Support TMF filing
• Contribute to process improvement and share knowledge & share knowledge and experience

• Bachelor’s degree
• Associate’s degree and 4 years of clinical execution experience
• High school diploma / GED and 6 years of clinical execution experience
• 2 years' work experience in life sciences or medically related field
• 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
• 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
• Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions
• Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
• Ability to maintain accurate and timely data entry
• Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
• Cultural sensitivity and collaboration across global teams
• Ability to recognize, highlight and resolve issues
• Demonstrates curiosity and willingness to take on new tasks

Reasonable accommodation for individuals with disabilities