Clinical Trial Manager

Damora Therapeutics is a biotechnology company developing therapies for blood disorders. The Clinical Trial Manager leads operational planning, execution, and oversight of an early-phase hematology/oncology clinical trial, coordinating internal teams and external vendors to ensure quality, compliance, and timely delivery.

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

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

Hematology/Oncology Trials

Rare Disease Studies

MPN Studies

Phase 1/1b Trials

Biotech Experience

Global Trial Conduct

Multi-Region Trial Conduct

Regulatory Nuances

Project Management

PMP Certification

IND-Enabling Studies

Registration-Track Studies

Company

Biotechnology developing targeted biologics for myeloproliferative neoplasms

Waltham, Massachusetts, USA

https://damoratx.com/

Founded in 2025

11-50 employees

Qualifications

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

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

Required skills

Clinical Trial Management, ICH-GCP, FDA Clinical Research Regulations, CRO and Vendor Management, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Hematology/Oncology Clinical Trials, Early-Phase Clinical Trials, Global Clinical Trial Conduct, Project Management Professional (PMP)

Preferred skills

Waltham, Massachusetts, USA, https://damoratx.com, Total Funding, unknown, 2026-02-01, Seed, 2025-11-10, Acquired, Recent News, BioSpace, 2026-10-07, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

3+ years