About the role
Seaport Therapeutics is a clinical-stage therapeutics 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 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 metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com . 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. The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” 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. Key
Responsibilities: 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. Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans. Responsible for management of CROs and other vendors Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc. Develop timelines and budgets for assigned studies and is responsible for delivery to both quality and agreed timelines. Project leadership of the cross-functional study team, including external team members, CROs and vendors. Plan, negotiate, and manage site budgets as well as facilitate site contracting process. Develop and implement robust contingency and issue management plans to solve complex issues that impact study milestones. Disseminate clinical trial communications to all functional groups and leads study and team meetings. Interact with clinical research investigators, Key Opinion Leaders and sites. May interact with Senior Management to report on progress of milestones. Oversight of study team and site training Facilitation of Quality processes and Quality Assurance interactions for assigned project(s) Management of study drug distribution and accountability processes and documentation Oversight of study start-up, study management, data cleaning, and study closeout activities Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival Provides review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
