Job Title: Clinical Trial Project Manager
Location: On-site (Watertown, MA)
Role Type: Full-time
Department: Clinical Operations
Reports to: VP, Clinical Operations
About Us:
Diagonal Therapeutics is a biotech company advancing novel disease-modifying clustering antibodies that repair dysregulated signaling implicated in a range of illnesses. The Company's DIAGONAL Product Engine combines proprietary computational and experimental techniques to overcome historical challenges associated with antibody drug discovery and efficiently deliver optimized therapeutic assets. Diagonal’s pipeline comprises clustering antibodies designed to selectively address the underlying cause of disease across hematology, hepatology, and nephrology, offering the potential to deliver life-changing therapies for patients.
Position Summary:
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. This role serves as the operational lead across cross-functional teams, vendors, and clinical sites, playing a critical role in advancing the company’s clinical development programs.
Duties & Responsibilities:
Trial Management
- 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
Cross-Functional & Vendor Oversight
- 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
Study Start-Up & Site Management
- 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)
Operational Reporting & Documentation
- 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
Process Improvement
- Contribute to the development and refinement of clinical operations processes and SOPs
- Identify opportunities to improve efficiency, quality, and scalability of clinical trial execution
Required Qualifications & Experience:
• 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
Desired Skills:
• 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
Compensation & Benefits:
Diagonal offers a competitive compensation package, including an annual bonus, and equity-based compensation. Benefits include contributions to a tax-advantaged health savings account and comprehensive medical, dental, and vision insurance.
We recognize the value of diversity in our workforce and are committed to equal opportunity. We consider all qualified employment applicants regardless of race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment in the United States will be considered without regard to citizenship/alienage.
