Our Opportunity...
We are looking for a highly motivated Clinical Trial Associate, with a background in Oncology and/or Cell Therapy clinical trials. As a key contributor within Clinical Operations, you'll help drive the development of our first clinical stage autologous cell therapy trial targeting solid tumors.Â
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. Â
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.Â
This is a Hybrid role based out of our Bedford, MA location. Â
You Will...
Core responsibilities
-  Support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.Â
- Serve as a point of coordination across internal teams, CROs, and external partners.Â
- Maintain the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.Â
- Perform TMF quality control activities and proactively address gaps.Â
- Support audits and inspections, including preparation and follow-up activities.Â
- Coordinate with vendors, including central labs and specialty service providers.Â
- Support biospecimen tracking, logistics, and associated documentation.Â
- Track and monitor vendor performance and escalate issues as needed.Â
- Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).Â
- Ensure data accuracy and timely reporting across study activities.Â
- Contribute to improvements in clinical operations processes and systems.Â
- Facilitate clear, timely communication across study teams and stakeholders.Â
- Coordinate study meetings, including agenda development, minutes, and follow-up actions.Â
- Maintain version control and documentation across clinical materials.Â
- Support invoice tracking, purchase order coordination, and budget-related activities.Â
You Bring...
Core Qualifications
- BS/BA/RN Degree with 3+ years of experience in a life science or a health-related field is preferred.Â
- 1+Â years working on phase I-IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.Â
- Experience and understanding of clinical trial operations, preferably in oncology and/or cell therapy space.Â
- Solid knowledge of ICH/GCP and regulatory requirements.Â
- Excellent planning, coordination, and time management skills Â
- Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership. Â
- Ability to build andmaintainproductive relationships at all levels within and across internal teams, and with external partners.Â
- Collaborative and accountable - recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomesÂ
- Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.Â
- Flexible - adapts to change in a fast paced, rapidly developing environment Â
- Curious and humble - continuous learner, seeks and welcomes input/expertise of othersÂ
- Tenacious and resilient - is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.Â
Bonus Qualifications
- Proficiency in Microsoft Project or other project management programs.