Clinical Trial Manager

Damora Therapeutics, Inc. (Nasdaq: DMRA) is a Boston-based biotechnology company working to fundamentally redefine care for patients with blood disorders. Damora is advancing a new generation of subcutaneous biologics targeting mutant calreticulin (mutCALR)-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis — chronic hematologic cancers with significant unmet need. The company’s lead program, DMR-001, is an investigational monoclonal antibody designed to selectively target mutant calreticulin, with additional programs (DMR-002 and DMR-003) advancing behind it.

The Clinical Trial Manager is responsible for the operational planning, execution, and oversight of a large early-phase hematology/oncology clinical trial within a small, fast-paced biotechnology company. This role provides hands-on oversight across all aspects of trial management, ensuring study activities are conducted in accordance with the clinical protocol and any amendments, ICH-GCP, applicable regulatory requirements, and company quality standards. The Clinical Trial Manager partners closely with Clinical Operations leadership, Clinical Development, Medical Monitoring, Regulatory Affairs, Clinical Data Management, Pharmacovigilance, and external vendors to drive study progress, maintain data quality, manage timelines and budgets, and proactively identify and mitigate operational risks.

Given the size, global footprint and complexity of the study and the lean organizational structure, this individual is expected to operate with a high degree of detail, accountability, and flexibility in the study’s day-to-day execution. The role is instrumental in supporting patient identification, recruitment, safety, site identification, activation and performance, inspection readiness, and the successful delivery of high-quality clinical data to advance the development of innovative therapies for patients with hematologic malignancies.

• Serve as an operational point of contact for assigned clinical trial(s), including CLARITY-101, including day-to-day execution tasks that assist site activation through database lock
• Work in coordination with and oversee CROs, central labs, and other third-party vendors; hold them accountable to contracted scope, timelines, and quality standards
• Maintain trial timelines, enrollment, pre-screening and all other clinical trial trackers, maintain risk logs; oversight plans, update all clinical documents following any protocol amendments and updates.
• Proactively identify and resolve issues with the team affecting timelines, budget, or data quality
• Work with the translational team to oversee the distribution of lab kits, site materials, follow-up on lab samples
• Oversee site identification, feasibility, selection, activation, and ongoing site management processes. This would include coordinating with the CRO operations and regulatory teams on essential document collection, review of green light packages for sites, receipt of materials needed by sites and ensuring and site readiness
• Support development and review of trial-related documents (protocols, informed consent forms, monitoring plans, CRFs) in collaboration with Clinical, Regulatory, Biostatistics, and Data Management
• Track and support resolution of protocol deviations, safety reportables, and audit/inspection findings
• Ensure trial conduct adheres to ICH-GCP, FDA regulations, and Damora's SOPs, including the review of CRO SOPs and assistance with the creation and review of all Damora Clinical SOPs.
• Coordinate and assist with cross-functional trial team meetings; prepare status update materials for internal stakeholders in coordination with the Director of Clinical Operations
• Contribute…