Senior Clinical Trial Associate - Oncology
Obsidian Therapeutics · Bedford, MA
- On site
- Full-time
- $120,000 / year
- Bedford, MA
Job highlights
- Drive oncology clinical trial operations execution.
- Oversee vendors and Trial Master File.
- Ensure regulatory compliance and data accuracy.
- Collaborate with internal and external teams.
- Contribute to process improvements.
About the role
About Us
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
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.
Key skills/competency
- Clinical Trial Operations
- Oncology Clinical Trials
- ICH/GCP Compliance
- Trial Master File (TMF) Management
- Vendor Oversight
- Biospecimen Logistics
- Cross-functional Coordination
- Data Accuracy and Reporting
- Process Improvement
- Communication Skills
Skills & topics
- Senior Clinical Trial Associate
- Oncology
- Clinical Trials
- Biopharmaceutical
- Biotech
- CRO
- GCP
- TMF
- Cell Therapy
- Gene Therapy
- Regulatory Affairs
- Project Management
- Data Management
- Clinical Operations
- BS/BA/RN Degree
How to get hired
- Tailor your resume: Highlight your oncology clinical trial experience and GCP knowledge.
- Showcase collaboration: Emphasize your ability to work with diverse teams and partners.
- Demonstrate leadership: Detail your experience in vendor oversight and TMF management.
- Prepare for behavioral questions: Be ready to discuss your adaptability and problem-solving skills.
- Research Obsidian Therapeutics: Understand their innovative cell and gene therapies and company culture.
Technical preparation
Behavioral questions
Frequently asked questions
- What are the key responsibilities for a Senior Clinical Trial Associate at Obsidian Therapeutics?
- As a Senior Clinical Trial Associate at Obsidian Therapeutics, you will be responsible for executing and supporting day-to-day clinical trial operations, managing the Trial Master File (TMF), overseeing vendors, ensuring data accuracy, and fostering cross-functional coordination. Your role is crucial in ensuring high-quality, inspection-ready study delivery for oncology clinical trials.
- What qualifications are essential for the Senior Clinical Trial Associate role at Obsidian Therapeutics?
- Essential qualifications include a BS/BA/RN degree with 6+ years of life science experience, including at least 3 years in Phase I-IV clinical studies. Experience in oncology and/or cell therapy clinical trial operations, and a solid understanding of ICH/GCP and regulatory requirements are crucial. Strong planning, communication, and relationship-building skills are also necessary.
- What is the work arrangement for this Senior Clinical Trial Associate position?
- This is a Hybrid role based out of Obsidian Therapeutics' facility in Bedford, MA. This means you will be expected to work a combination of days in the office and remotely.
- What is the expected salary range for the Senior Clinical Trial Associate role?
- The anticipated base salary range for this position is $108,000 to $132,000 USD annually. This range may be adjusted based on factors such as experience, education, and location. The total compensation package also includes annual incentive bonuses and long-term incentives.
- What is Obsidian Therapeutics' approach to clinical trials and patient care?
- Obsidian Therapeutics is focused on pioneering engineered cell and gene therapies, particularly utilizing their cytoDRIVE® technology. Their lead program targets metastatic melanoma and non-small cell lung cancer, aiming to deliver transformative outcomes for patients through innovative science and medical breakthroughs.
- How does Obsidian Therapeutics foster a positive work environment for its employees?
- Obsidian Therapeutics is committed to cultivating an inclusive environment where employees feel a strong sense of belonging and are supported to learn and contribute. They value a highly collaborative culture, offer competitive salaries and benefits, and provide opportunities for ownership through stock options.