<p>PureTech Health is seeking a highly motivated and team goal oriented Senior Clinical Trial Manager (CTM) with clinical trial experience to execute late-stage global clinical trial(s) and help us build our Clinical Operations team. In this highly visible role, you will report to the Vice President of Clinical Operations and work closely with a very collaborative cross functional team. You will have exposure to our senior leaders, be integral in the decision-making process, and be at the forefront of scientific innovation and business growth. For the Senior CTM role, this individual should have strong organizational skills, CRO and vendor management experience and a strong working knowledge of FDA Regulations and GCP/ICH guidelines. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of PureTech's products. This is a unique opportunity for the right candidate to grow their career and help shape the future of our company.</p> <p>Responsibilities:</p> <ul> <li>Independently manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plans; manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor deliverables, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings (e.g., Study Team Meetings, internal project team meetings, etc.) as applicable; participates in site monitoring visits as appropriate. </li><li>Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; supports the creation of the ICF template, CRFs, etc. </li><li>Interface with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff). </li><li>Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.). </li><li>Assists in development of site budget </li><li>Reviews the electronic trial master file (eTMF) and works with CRO and functional area representatives to ensure an inspection ready eTMF. </li><li>Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or IRB/ethics committee activities, as appropriate. </li><li>Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. </li><li>Coordinate and participate in data reviews in conjunction with CRO/ Data Management staff </li><li>Participate in review and revision of departmental SOPs, provide support to establish and maintain operational infrastructure </li></ul> <p>Requirements</p> <ul> <li>BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of 5 years of managing global clinical studies </li><li>Experience and understanding of global clinical trial operations </li><li>Experience working in the therapeutic area of Respiratory Therapy </li><li>The ability to independently lead and manage multiple projects simultaneously, prioritize workload, an adaptive working style and a creative and thoughtful approach to problem solving </li><li>CRA experience performing onsite monitoring visits preferred but not required </li><li>Ability to follow and implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessary </li><li>Experience managing CROs, vendors, and/or clinical trial consultants </li><li>Thrives in a fast-paced and evolving environment </li></ul>