Clinical Trial Manager

Company Overview

Seaport Therapeutics is a clinical-stage company focused on developing innovative neuropsychiatric medicines addressing significant unmet patient needs. Utilizing its proprietary GlyphTM technology platform, the company advances clinically validated mechanisms that overcome previous limitations such as poor oral bioavailability, first-pass metabolism challenges, hepatotoxicity, and other side effects. Led by an experienced team with a strong background in neuropsychiatric drug development and guided by leading scientists and clinicians, Seaport aims to deliver first and best-in-class therapies.

Position Summary

We are seeking a Clinical Trial Manager (CTM) to lead the planning and execution of clinical studies ensuring timely and budget-compliant delivery. The role requires a collaborative individual who embodies our patient-centered values, entrepreneurial mindset, and commitment to excellence. The position is based in Boston's Seaport area with a preference for onsite presence four days a week.

Key Responsibilities

• Lead and oversee clinical study projects critical to product development, ensuring compliance with SOPs, regulations, and ICH/GCP standards.
• Assist in selecting and managing external vendors including developing RFPs and vendor oversight plans.
• Manage Contract Research Organizations (CROs) and other third-party vendors involved in clinical trials.
• Contribute to the design of informed consent forms, electronic case report forms (eCRFs), monitoring standards, and data quality checks.
• Create and manage study timelines and budgets, ensuring delivery within agreed parameters.
• Lead cross-functional study teams comprising internal and external members, including CROs and vendors.
• Negotiate and manage site budgets and oversee site contracting processes.
• Develop contingency and issue management plans to address challenges impacting study milestones.
• Coordinate clinical trial communications across functional groups and lead study meetings.
• Engage with clinical research investigators, key opinion leaders, and clinical sites.
• Report study progress to senior management as necessary.
• Supervise study team and site training activities.
• Support quality assurance and facilitate quality processes related to assigned projects.
• Manage study drug distribution, accountability, and related documentation.
• Oversee all phases of the study lifecycle including startup, management, data cleaning, and closeout.
• Ensure proper maintenance of final study documentation such as Trial Master Files (TMF), Final Tables, Listings, and Figures (TLFs), and archived study data.
• Contribute to the development and review of study protocols, plans, CRFs, and informed consent forms.

Qualifications

• Bachelor's degree in Health or Life Sciences.
• At least 4 years of experience in a Clinical Trial Manager role or demonstrating equivalent capabilities.
• Strong communication and interpersonal skills.
• Positive, team-oriented attitude.
• Self-motivated, reliable, and detail-focused with excellent organizational abilities.
• Skilled at managing multiple priorities concurrently.
• Creative problem-solving aptitude.
• Willingness and ability to travel as required.
• Experience in central nervous system (CNS) therapeutic area is highly desirable.

Compensation and Culture

Seaport Therapeutics values transparency, fairness, and a culture of trust and collaboration. The position offers a salary range from $133,000 to $150,000 per year, dependent on experience, market conditions, and internal equity. We encourage early dialogue about compensation to ensure alignment throughout the hiring process.