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Generate Biomedicines, a clinical-stage generative biology company using AI to design protein-based medicines, is seeking a Clinical Trial Manager to support late-stage clinical trial operations. Reporting to the Director of Clinical Operations, you will serve as the day-to-day operational coordinator across assigned studies, working within a vendor-managed model where clinical execution is carried out through a network of CROs and specialized vendors.
Key responsibilities include: serving as the primary operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines while flagging risks to leadership; reviewing CRO-generated documents (monitoring reports, site correspondence, protocol deviations, TMF entries) for completeness and quality; supporting study startup activities including site activation tracking and regulatory document collection; maintaining study trackers, timelines, and action logs to ensure cross-functional visibility; attending and documenting study team meetings while tracking action items; triaging and coordinating resolution of protocol deviations; supporting safety reporting coordination including SAE/SUSAR tracking; monitoring TMF completeness and inspection readiness; tracking IRB/IEC approvals across sites; compiling enrollment and operational metrics for leadership; supporting data reviews and monitoring visit quality assurance; reviewing and reconciling CRO invoices against contracted activities; coordinating data reconciliation at key milestones; and onboarding new clinical team members.
Ideal candidates have a bachelor's degree (scientific or health-related field preferred) and 6+ years of clinical operations, clinical research, or related experience, with sponsor-side background a plus. Required competencies include foundational understanding of GCP and ICH guidelines, experience coordinating with CROs, strong attention to detail, ability to manage multiple concurrent trackers and timelines, familiarity with clinical trial systems (CTMS, EDC, eTMF), and clear communication skills. Familiarity with oncology, immunology, or respiratory therapeutic areas is a plus. Up to 20% domestic and/or international travel required.
