TScan Therapeutics is a clinical stage biotech seeking to revolutionize life changing therapeutics for patients by identifying novel T cells and epitopes We are looking for a Senior Clinical Trial Manager to support these studies The ideal candidate should have relevant experience in oncology and cell therapy clinical studies and should thrive in a fast paced collaborative and vibrant startup culture A team player with a sense of urgency will succeed in this role Responsibilities Lead all operational aspects of Phase IIII clinical trials from study start up through study close out Develop and maintain study operational plans timelines and key deliverables Ensure studies are conducted in accordance with ICH GCP FDA regulations company SOPs and applicable regulatory requirements Lead cross functional study team meetings and drive execution of study objectives Identify operational risks and develop mitigation strategies to maintain study timelines Track study milestones and proactively communicate study status risks and mitigation plans to management Support protocol development by providing operational input and reviewing study related documents Participate in study feasibility assessments country and site selection and enrollment planning Lead investigator meetings site initiation activities and ongoing site engagement strategies Review enrollment metrics site performance and study quality metrics to identify trends and drive improvements Partner with CRAs to address site performance issues protocol compliance and enrollment challenges Lead vendor meetings monitor vendor performance review key performance indicators and ensure contractual deliverables are met Review and approve vendor plans study documentation and operational deliverables as appropriate Support operational activities related to cell therapy studies including manufacturing scheduling apheresis coordination chain of identity chain of custody and product logistics Ensure Trial Master File TMF documentation is complete accurate and inspection ready throughout the study lifecycle Monitor TMF quality metrics and ensure timely filing of essential documents Support internal audits quality reviews regulatory inspections and implementation of corrective and preventive actions Review study budgets forecasts purchase orders invoices and vendor expenses in collaboration with Clinical Operations leadership Contribute to development and continuous improvement of Clinical Operations processes SOPs work instructions and study management tools Mentor junior team members and provide guidance to study team members as needed Foster collaborative relationships with investigators study sites vendors and internal stakeholders Perform other duties as assigned to support Clinical Operations objectivesRequirements Bachelors degree in a scientific or healthcare discipline preferred with at least 810 years of experience in a clinical research environmentCell Therapy andor hematology experience preferredExperience leading Phase I III oncology clinical trials Understanding of drug development and familiarity with FDA and ICH GCP guidelines associated with conduct of clinical researchExcellent interpersonal written and spoken communication skillsAbility to work in a flexible matrix environmentGood organizational skills and attention to detailSelf motivated with a willingness to learnAbility to take direction and manage multiple tasks About TScan TScan Therapeutics is a fully integrated next generation TCR T cell therapy company Founded in 2018 TScans platform was developed by Stephen Elledge PhD and Tomasz Kula PhD at Brigham and Womens Hospital and Harvard Medical School TScans transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers including autoimmune disorders and infectious diseases Do YOU have the anatomy of a TScanner Our talented compassionate and intelligent team is what makes TScan a Top Place to Work as ranked by The Boston Globe Our state of the art offices with over 70000 square feet of premium lab space including an internal GMP manufacturing suite are an environment that supports innovation camaraderie and professionalism We are passionate fun flexible and team oriented Sound like you Apply today EEO Statement TScan is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race color religion age sex national origin disability status genetics protected veteran status citizenship status sexual orientation gender identity or expression or any other characteristic identified by federal state or local laws where we operate TScan provides reasonable accommodations to qualified applicants and employees with disabilities To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process andor to perform the responsibilities of the position for which the applicant has applied please contact the recruiter Pay Range 170000 187000 Pay Transparency TScan Therapeutics pay ranges are established based on external market data from third party compensation surveys and our internal benchmarking This role is eligible for an annual bonus and annual equity awards Some roles may also be eligible for overtime pay in accordance with federal and state requirements Individual compensation within this range is commensurate with a candidates specific qualifications including education overall experience relevant experience and specific skills We strive to ensure that compensation is competitive equitable and aligned with the value each TScanner brings to the role Recruitment & Staffing Agencies TScan Therapeutics does not accept unsolicited resumes from any source other than candidates The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics internal Talent Acquisition team Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics and TScan Therapeutics will not owe any referral or other fees with respect thereto