Senior Clinical Trial Manager at Insmed in Corporate Headquarters, NJ

Job description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We are seeking a Senior Clinical Trial Manager who will be responsible for the management and oversight of global phase I-IV clinical trials from start up through Clinical Study Report (CSR). You will be responsible for the development of project documentation, mentoring and coaching newly onboarded staff, Clinical Trial Associates (CTAs), and Clinical Trial Managers (CTMs), and monitoring study progress. You will manage the administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. You will provide key global trial management support to the Clinical Operations team (e.g., feasibility, start-up, maintenance, and close-out). What You'll Do: In this role, you’ll have the opportunity to lead and coordinate the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines as well as may act as Clinical Operations Leader (COL), accountable for trial performance. You’ll also: Provide detailed management and oversight of regional/global trial activities, as assigned. Accountable for achieving site activations and enrollment milestones in assigned region. Coordinate cross-functional study clinical team activities to ensure deliverables are completed with high quality, within agreed timelines, and on budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning. Develop and manage detailed project and other trial-related plans and documentation and provides regular study status updates to senior management. Review and contribute to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials. Create, review and approve specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans. Liaises with CRO and legal to provide language acceptable for IRB’s/EC’s. Drive timely and efficient execution of site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets. Collaborate with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences. Accountable for development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites. Participate in risk-based quality management (RBQM) activities to ensure data integrity and patient safety. Implement risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials. Support COL with planning, and may attend and present at investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings. Responsible for end-to-end vendor management from study planning to close-out, through regul