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Seaport Therapeutics · 1 day ago

Clinical Trial Manager

Boston, MA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Seaport Therapeutics is a clinical-stage biopharmaceutical company focused on developing neuropsychiatric medicines. The Clinical Trial Manager will lead the execution of clinical studies, ensuring they are completed on time and within budget while complying with regulations and guidelines.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Clinical Trials ManagementCNS Therapeutic ExperienceVendor ManagementRegulatory ComplianceProject LeadershipCommunication SkillsTeam PlayerProblem SolvingOrganizational Skills