Senior Clinical Trial Management Associate

$110,200 - $135,000/Yr

Arsenal Biosciences - South San Francisco, CA

Full-time - Mid Level

South San Francisco, CA

About the position

The Senior Clinical Trial Management Associate at Arsenal Biosciences Inc. plays a crucial role in supporting all aspects of clinical trial conduct, including study start-up, enrollment, study conduct, and close-out. This position is integral to the company's mission of engineering advanced CAR T-cell therapies for solid tumors, working collaboratively with internal teams and external partners to ensure the successful execution of clinical trials. The role requires a deep understanding of clinical research operations and the ability to thrive in a fast-paced, dynamic environment.

Responsibilities

• Assist in all operational aspects of assigned clinical trials, including supporting the full trial process from vendor selection and study start-up through enrollment, ongoing study conduct, and close-out.
• Assist in reviewing study-related and essential clinical study start-up documents such as Clinical protocols, Informed consent forms, and other relevant study plans.
• Responsible for apheresis planning to support enrollment of study participants and liaise with investigative sites and supply chain.
• Coordinate with supply chain on all aspects of study participant sample collection and the 'cell journey'.
• Collaborate with translational operations on biospecimen sample routing, tracking, and query resolutions.
• Assist with the review of IRB/EC documents in coordination with CRO, as appropriate.
• Assist in site selection and the start-up processes toward activating sites.
• Responsible for filing necessary documents in the electronic trial master file (eTMF).
• Maintain tracking of various study activities to assist the study lead with required updates for senior leadership.
• Assist in data review and/or data metric review in preparation for data cuts.
• Assist in training and managing CRO and vendors such as Central lab, Imaging, etc.
• Assist in CRO interactions, including sponsor oversight of operational functional activities.
• Develop productive relationships with investigators and site staff and serve as a liaison for investigational sites.
• Participate in the development, review, and implementation of departmental SOPs and processes.

Requirements

• BS/BA in nursing, science or health-related field with 4+ years of related oncology clinical trial management experience.
• Competent knowledge of transplant patient care and apheresis collection is a plus.
• Clinical research knowledge and cross-functional understanding of the clinical trial methodology.
• Willingness to travel to clinical sites as needed.
• Strong analytical and problem-solving skills.
• Outstanding attention to detail and organizational skills with the ability to multi-task and prioritize.
• Demonstrated excellence in interpersonal, verbal, and written communication skills.

Nice-to-haves

• Experience in transplant care
• Familiarity with FDA regulations/ICH guidelines
• Creative and innovative mindset to approach novel problem statements

Benefits

• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Parental leave
• Vision insurance