Clinical Trial Manager at Seaport Therapeutics

<p>Seaport Therapeutics is a clinical-stage&nbsp;therapeutics&nbsp;company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary&nbsp;GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass&nbsp;metabolism&nbsp;and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and&nbsp;are&nbsp;guided by an extensive network of renowned scientists,&nbsp;clinicians&nbsp;and key opinion leaders. For more information, please visit <a href="https://www.seaporttx.com/">www.seaporttx.com</a>.&nbsp;</p> <p>&nbsp;</p> <p>Seaport Therapeutics is seeking a Clinical Trial Manager to join our Development team. The Clinical Trial Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget.</p> <p>The ideal candidate will embrace a collaborative, innovative culture that embodies our values of <em>service </em>to patients impacted by mental health conditions, with a <em>“we own it”</em> mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week.</p> <p><strong>Key Responsibilities:</strong></p> <ul> <li>Accountable for project related efforts for the delivery of studies that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.</li> <li>Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.</li> <li>Responsible for management of CROs and other vendors</li> <li>Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.</li> <li>Develop timelines and budgets for assigned studies and is responsible for delivery to both quality and agreed timelines.</li> <li>Project leadership of the cross-functional study team, including external team members, CROs and vendors.</li> <li>Plan, negotiate, and manage site budgets as well as facilitate site contracting process.</li> <li>Develop and implement robust contingency and issue management plans to solve complex issues that impact study milestones.</li> <li>Disseminate clinical trial communications to all functional groups and leads study and team meetings.</li> <li>Interact with clinical research investigators, Key Opinion Leaders and sites.</li> <li>May interact with Senior Management to report on progress of milestones.</li> <li>Oversight of study team and site training</li> <li>Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)</li> <li>Management of study drug distribution and accountability processes and documentation</li> <li>Oversight of study start-up, study management, data cleaning, and study closeout activities</li> <li>Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival</li> <li>Provides review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>BA/BS degree in Health or Life Sciences required</li> <li>Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role</li> <li>Exceptional communication and interpersonal skills</li> <li>Positive team orientated attitude</li> <li>Reliable, self-motivated, team player</li> <li>Detail oriented with excellent organizational skills</li> <li>Ability to effectively manage multiple tasks and competing priorities</li> <li>Creative problem solver</li> <li>Ability to travel is required</li> <li>CNS therapeutic experience strongly preferred</li> </ul> <p>&nbsp;</p> <p>At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is ($133,000 - $150,000) with the final offer based on experience, market data, and internal equity.</p> <p>We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.</p>