Diagonal Therapeutics · 8 hours ago
Clinical Trial Project Manager
Boston, MA
Full-time
Onsite
Senior Level
7+ years expDiagonal Therapeutics is a biotech company advancing novel disease-modifying clustering antibodies. The Clinical Trial Project Manager (CTPM) is responsible for the planning, execution, and oversight of clinical trials to ensure delivery on time, within scope, budget, and in compliance with regulatory and quality standards.
BiopharmaBiotechnologyLife ScienceMedicalTherapeutics
Hiring Manager
Le Nguyen
Responsibilities
Lead end-to-end clinical trial execution from study start-up through close-out
Develop and manage clinical trial plans, timelines, budgets, and risk mitigation strategies
Track study progress and proactively identify and resolve operational issues
Ensure adherence to protocol, SOPs, ICH-GCP, and applicable regulatory requirements
Serve as the primary point of contact for CROs, vendors, and functional partners
Manage vendor performance, contracts, deliverables, and invoices
Coordinate cross-functional teams including Clinical Operations, Data Management, Biostatistics, Regulatory, Medical, and Quality
Oversee site feasibility, selection, initiation, monitoring, and close-out activities
Support investigator meetings and site communications
Review and approve key study documents (e.g., monitoring plans, enrollment projections, status reports)
Prepare and deliver regular study status updates to internal stakeholders and senior leadership
Maintain accurate and inspection-ready Trial Master File (TMF)
Support audits, inspections, and regulatory submissions as needed
Contribute to the development and refinement of clinical operations processes and SOPs
Identify opportunities to improve efficiency, quality, and scalability of clinical trial execution
Qualification
Required
Bachelor's degree in life sciences, nursing, or a related field
7+ years of experience in clinical research experience, including hands-on clinical trial management
Strong knowledge of ICH-GCP, FDA, and global regulatory requirements
Proven ability to manage multiple priorities in a fast-paced biotech environment
Preferred
Global clinical trial and therapeutic area experience in rare diseases
Outstanding verbal and written communication skills
Strong project management and organizational skills
Able to work effectively across functions
Detail-oriented with a proactive, problem-solving mindset
Comfortable operating in a resource-lean, high-growth environment
Benefits
Annual bonus
Equity-based compensation
Contributions to a tax-advantaged health savings account
Comprehensive medical, dental, and vision insurance
Company
Diagonal Therapeutics
Diagonal Therapeutics is a biotechnology startup that develops targeted therapies for cancer and genetic diseases.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$253M2026-01-08Series B· $125M
2024-04-03Series A· $128M
Leadership Team
Alexey Lugovskoy
Founder, President, and CEO
Recent News
2026-01-23
vcnewsdaily.com
2026-01-14
Company data provided by crunchbase