Senior Clinical Trial Associate - Oncology - Obsidian Therapeutics

Our Opportunity...

We are looking for a highly motivated Senior Clinical Trial Associate, with a background in oncology clinical trials. As a key contributor within Clinical Operations, you’ll help to drive the development of our first clinical stage autologous cell therapy trial targeting solid tumors. 

You’ll play a key role in driving the operational execution of complex clinical trials, supporting cross-functional coordination, vendor oversight, and ensuring high-quality, inspection-ready study delivery. As a member of our Clinical Operations Team, you will be a vital part of a highly collaborative organization working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.  

This is a unique opportunity to be a contributor in a well-funded clinical stage company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

This is a Hybrid role based out of our Bedford, MA location.  

You Will...

Core responsibilities

• Execute and support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements. 
• Serve as a key point of coordination across internal teams, CROs, and external partners. 
• Maintain and oversee the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness. 
• Lead TMF quality control activities and proactively address gaps. 
• Support audits and inspections, including preparation and follow-up activities. 
• Coordinate and oversee vendors, including central labs and specialty service providers. 
• Manage biospecimen tracking, logistics, and associated documentation. 
• Monitor vendor performance and escalate issues as needed. 
• Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines). 
• Ensure data accuracy and timely reporting across study activities. 
• Contribute to improvements in clinical operations processes and systems. 
• Drive clear, timely communication across study teams and stakeholders. 
• Plan and facilitate study meetings, including agenda development, minutes, and follow-up actions. 
• Maintain version control and documentation across clinical materials. 
• Support invoice tracking, purchase order coordination, and budget-related activities. 

You Bring...

Core Qualifications

• BS/BA/RN Degree with 6+ years of experience in a life science or a health-related field is preferred. 
• 3+ years working on phase I-IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment. 
• Experience and understanding of clinical trial operations, preferably in oncology and/or cell therapy space. 
• Solid knowledge of ICH/GCP and regulatory requirements. 
• Excellent planning, coordination, and time management skills   
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   
• Ability to build and maintain productive relationships at all levels within and across internal teams, and with external partners.   
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes 
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – continuous learner, seeks and welcomes input/expertise of others 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency. 

Bonus Qualifications

• Proficiency in Microsoft Project or other project management programs.