Clinical Trial Manager

Damora Therapeutics; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Damora Therapeutics, Inc. is seeking a Clinical Trial Manager to lead operational planning, execution, and oversight of a large early-phase hematology/oncology trial in a fast-paced biotech environment.

You will collaborate across Clinical Operations, Medical Monitoring, Regulatory, Data Management, and vendors to drive study progress and data quality, while managing timelines and budgets. The role focuses on site activation, vendor management, and regulatory compliance, with a hands-on approach

Qualifications

• Bachelor's degree in life sciences, nursing, or related field is required.
• 3+ years of clinical trial management experience in biotech, pharma, or CRO settings with oversight of timelines, budgets, and vendors.
• Working knowledge of ICH-GCP guidelines and FDA regulations governing clinical research.
• Experience managing CRO and vendor relationships, including performance oversight and issue escalation.
• Strong ability to manage multiple priorities and stakeholders in a fast-paced, cross-functional environment.
• Proficiency with CTMS, EDC platforms, and standard office software.

Responsibilities

• Serve as an operational point of contact for assigned clinical trial(s), including day-to-day execution tasks that assist site activation through database lock
• Oversee CROs, central labs, and other third-party vendors to ensure contracted scope, timelines, and quality
• Maintain trial timelines, enrollment, pre-screening and trial trackers, risk logs, oversight plans, and updated documents
• Identify and resolve issues affecting timelines, budget, or data quality
• Coordinate with translational team to oversee lab kits distribution and specimen follow-up
• Oversee site identification, feasibility, activation, and ongoing site management processes with CRO/regulatory teams
• Support development and review of trial-related documents (protocols, ICFs, monitoring plans, CRFs)
• Track/provide resolution for protocol deviations, safety reportables, and audit/inspection findings
• Ensure trial conduct adheres to ICH-GCP, FDA regulations, and Damora SOPs
• Coordinate cross-functional trial team meetings; prepare status updates with Director of Clinical Operations
• Contribute to study-specific plans (monitoring, communication) and cross-functional oversight plans
• Oversee Trial Master File filing for CRO and internal teams

Skills

Organizational skills

Written & verbal communication

Multi-stakeholder management

Problem solving

Education

Bachelor's degree in life sciences, nursing, or related field

Tools

CTMS

EDC platforms

Job description

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.

Position Summary

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.

Key Responsibilities

• 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 to development of study-specific plans (monitoring, communication etc.) and cross-functional oversight plans.
• Oversee the Trial Master File filing processes for the CRO, the internal cross-functional team and vendors.

Qualifications

Required

• Bachelor's degree in life sciences, nursing, or related field
• 3+ years of clinical trial management experience in biotech, pharma, or CRO setting, with direct oversight of trial timelines, budgets, and vendors
• Working knowledge of ICH-GCP guidelines and FDA regulations governing clinical research
• Experience managing CRO and vendor relationships, including performance oversight and issue escalation
• Demonstrated ability to manage multiple priorities and stakeholders in a fast-paced, cross-functional environment
• Strong organizational, written, and verbal communication skills
• Proficiency with clinical trial management systems (CTMS), EDC platforms, and standard office software

Preferred

• Experience in hematology/oncology trials, particularly rare disease or myeloproliferative neoplasm (MPN) studies
• Prior experience in an early-phase (Phase 1/1b) clinical trial setting
• Experience at a small-to-mid-size biotech, where trial managers often carry broader scope than at larger organizations
• Familiarity with global/multi-region trial conduct and associated regulatory nuances
• Project management certification (e.g., PMP) or equivalent training
• Experience supporting IND-enabling or registration-track studies