Senior Clinical Trial Manager (CTM).

Accountabilities:

In this role, you will oversee clinical trial operations from initial protocol development through study closeout, ensuring compliance with applicable regulations and quality standards. You will work closely with internal teams and external collaborators to maintain study progress, manage risks, and improve clinical development processes.

• Lead the initiation, execution, and closeout of clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines and international regulatory requirements.

• Contribute to study concept development, protocol design, feasibility assessments, and study start-up activities.

• Manage strategic relationships and engagement with key collaborators and external stakeholders.

• Establish and maintain clinical trial trackers covering regulatory documentation, Trial Master Files (TMFs), start-up progress, screening and enrollment, invoices, payments, and project budgets.

• Contribute to Institutional Review Board (IRB), Ethics Committee (EC), and other regulatory submissions.

• Oversee TMF reviews to ensure documentation is complete, accurate, and inspection-ready.

• Review clinical documentation to verify compliance with Clinical Operations standards, project-specific quality requirements, standard operating procedures (SOPs), and training guidelines.

• Identify, assess, and mitigate study risks, escalating issues when necessary.

• Coordinate with cross-functional teams, including Quality Assurance, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance.

• Drive the adoption of best practices and continuous improvement initiatives across clinical development.

• Support data exchange, analysis, and interpretation to help generate reliable clinical evidence.

Requirements:

The ideal candidate combines substantial clinical trial management experience with strong operational knowledge, regulatory expertise, and the ability to lead projects across multiple functions. You should be comfortable working independently in a fast-paced environment while building productive relationships with colleagues and external partners.

• Bachelor's degree in a scientific field required; an advanced scientific degree is a plus.

• At least 5 years of direct clinical trial management experience in a sponsor or Contract Research Organization (CRO) setting.

• In-depth knowledge of clinical trial operations, ICH guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements.

• Experience directing or coordinating clinical operations team members.

• Proven ability to collaborate effectively across multiple functional areas and manage complex clinical projects.

• Strong project management, organizational, and time-management skills, with exceptional attention to detail.

• Demonstrated ability to identify risks, solve problems creatively, and make sound decisions under time pressure.

• Intellectual curiosity, an innovative mindset, and an entrepreneurial approach to improving clinical research.

• Ability to work autonomously while contributing effectively to a collaborative team.

• Excellent written and verbal communication skills, with the ability to build strong internal and external relationships.

• High standards of professionalism, integrity, accountability, and ethical conduct.

• Willingness and flexibility to travel to the Boston area as needed.

Benefits:

• Annual base salary: $168,000–$188,000 USD.

• Remote work within the United States, with travel to the Boston area as needed.

• Medical, dental, and vision insurance, with 99% of premiums covered.

• Company-paid life insurance, accidental death and dismemberment (AD&D) coverage, and disability benefits.

• Voluntary insurance plans to personalize coverage.

• Dollar-for-dollar 401(k) matching on eligible contributions, up to 6%.

• Long-term stock incentives and an Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonus.

• Flexible wellness benefit.

• Generous paid time off (PTO), paid holidays, and company-wide shutdowns.

• Opportunity to work with a collaborative team of knowledgeable, motivated, and supportive colleagues.