Senior Clinical Trial Management Associate (24004-B-615-MED)

Arsenal Bio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Sr. Clinical Trial Management Associate (Sr. CTMA) to work remotely.
ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer.  Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. 
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Sr. Clinical Trials Management Associate will support all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.  This role will require an ability to operate in a fast-paced, highly dynamic environment within a matrix team and have partnerships that include both internal and external stakeholders.  

What You Will Do:

• Assist in all operational aspects of the assigned clinical trial(s) and support the clinical trial(s) conduct including vendor selection process, study start-up, enrollment, study conduct, and close-out
• Assist in review of study-related and essential clinical study start-up documents (e.g., Clinical protocols, regulatory document packages, informed consent forms, CTA/Budget, Investigational Product Manual, Monitoring Plan, Laboratory Manual, Case Report Form (CRFs), CRF Completion Guidelines, training documentation/tools, and other relevant study plans and charters). 
• Assists in training and managing CRO and vendors such as Central lab, Imaging, etc 
• Assists in data review and/or data metric review in preparation for data cuts
• May be responsible for apheresis planning to support enrollment of study participants and liaise with investigative sites and supply chain to support activities involved in the cell journey
• May coordinate with supply chain on all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sites
• Responsible for biospecimen sample routing, tracking, and query resolutions between clinical sites and the central lab and CROs.
• Responsible for planning, coordinating, and tracking biospecimen shipments (PK, biomarkers) between central lab and specialty vendors
• Assists with the review of IRB/EC documents in coordination with CRO, as appropriate
• Assists in site selection and the start-up processes toward activating sites
• Responsible for filing necessary documents in the electronic trial master file (eTMF), and for leading regular cross-functional reviews of the eTMF.
• Maintain tracking of various study activities to assist the study lead with required updates required for senior leadership
• Assist in CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring report review, site management, TMF, EDC, etc). 
• Develops relationships with investigators and site staff as well as serve as a liaison and resource for investigational sites.
• Under supervision, participate in the development, review and implementation of departmental SOPs and processes.
• Support other studies as required and other duties as assigned

What Will You Bring:

• Your whole self
• BS/BA in nursing, science or health-related field with 4+ years experience of related oncology clinical trial management experience
• Experience with vendor management & CRO oversight preferred
• Competent knowledge of transplant patient care and apheresis collection is a plus
• Clinical research knowledge and cross-functional understanding of the clinical trial methodology
• Willing to travel to clinical sites as needed 
• Ability to deal with time demands, incomplete information, or unexpected events
• Must display strong analytical and problem-solving skills
• Attention to detail required
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal, and written communication skills are essential to working in a matrix team
• Creative and innovative mindset to approach novel problem statements 
• Willingness to learn and adapt to new technologies
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

What We Will Offer You: ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to med