Associate Operations Manager, Translational Medicine

• Work closely with the Operations Manager, Translational Medicine on the management and handling of clinical samples, both internally and externally, including supporting the shipping and receiving of clinical samples
• Sample quality oversight: Including surveying data sources for TMG sample collection, processing and transit issues. Record sample deviations, manage and track implementation of CAPAs where applicable, in collaboration with Central Lab vendor(s) and the Quality team
• Vendor Oversight: review invoices, evaluate vendor performance, build relationships with vendors and courier services
• Reconcile informed consent for the use of clinical biospecimens to support translational scientists and external partners
• Support on-site sample receiving and verification upon sample arrival
• Coordinate timely shipments of clinical samples from central labs to testing labs/CROs and to our in-house lab team
• Manage concurrent timelines for multiple internal projects
• Review relevant sections of clinical study related documents
• Support inventory buildout and testing workflows in TMG’s Laboratory Information Management System(s) (LIMS)
• Assist in timely review of CRO research contracts and invoices through communication with legal and finance groups respectively
• Enforce GLP-compliant and detailed record keeping protocols for clinical sample chain of custody (receipt, usage, etc.) within Cabaletta Bio
• Support TMG scientists in other related operational needs as project/priorities evolve

• BS in a biological sciences or biomedical engineering-related field with 3+ years of experience in clinical drug development or an equivalent combination of education and experience
• Experience in reviewing clinical protocol-associated documents including informed consent forms (ICFs) is highly preferred
• Experience with clinical sample handling and inventory management is highly preferred
• Knowledge of requirements for biospecimen acquisition to support downstream analyses (i.e., flow cytometry, immunoassays, PCR, NGS)
• Highly organized, with the capacity to prioritize and provide consistent, timely responses working both collaboratively and independently
• Strong communication skills required to interact effectively with internal and external stakeholders, senior management, and external CROs
• Management of contract research organizations is preferred
• Previous exposure to translational science operations in the cell therapy field, including biospecimen sample processing and handling, is advantageous
• Strong team orientation and passion for continuous self-development
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Previous experience with GLP/GCP & ICH regulations

• Experience in reviewing clinical protocol-associated documents including informed consent forms (ICFs) is highly preferred
• Experience with clinical sample handling and inventory management is highly preferred
• Management of contract research organizations is preferred
• Previous exposure to translational science operations in the cell therapy field, including biospecimen sample processing and handling, is advantageous

health and retirement, PTO, and stock option plans