Early-Phase Hematology Trial Manager

Damora Therapeutics; Waltham (MA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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

Connaissances

Organizational skills

Written & verbal communication

Multi-stakeholder management

Problem solving

Formation

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

Outils

CTMS

EDC platforms

Description du poste

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