Associate, Clinical Trial Operations

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’re looking for an Associate, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Clinical Trial Operations, you’ll assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines. You will also provide operational support for the Clinical Operations team, (e.g., feasibility, start-up, maintenance, and close-out, etc.) and work with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations. What You'll Do: In this role, you’ll have the opportunity to be responsible for the collection of trial-related documents and maintenance of both paper and electronic Trial Master File (TMF) and assist in periodic TMF quality control check through the course of study as defined by the clinical study team, per ICH/GCP requirements. You’ll also: Be responsible for the QC activities of the Sponsor- and CRO-supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to assist with performing audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts. Participate in the review of clinical trial agreements, work orders, and other site/vendor agreements. Assist in the review and processing of invoices related to study agreements. Assist with the tracking and documenting of site and sponsor training (e.g., Study specific, drug and program level). Participate in clinical study team and vendor meetings. Schedules meetings, drafts and finalize meeting action items. During CST meetings, provide update on health and currency of study TMF. Assist in review of CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials. Assist in coordinating activities related to Regulatory Inspection (e.g., prep, retrieval of documents and other activities and support). Support Vendor audits, when needed.  Process payments to vendors via Procurement system Who You Are: You have a Bachelor’s degree in life science, healthcare, or related field, along with 1 year of experience in pharmaceutical/biotech industry You are or you also have: Experience in clinical research and basic knowledge of Good Clinical Practice (GCP) and ICH guidelines in clinical trials Good verbal communication and writing skills, and good interpersonal/group skills Ability to demonstrate flexibility, agility and working within a multi-functional, global matrix Demonstrated efficiency with multi-tasking and prioritization Collaborative approach to process development, issue resolution/risk management Roll-up-your-sleeves orientation and a strong ability to work in a globally team-based environment Nice to have (but not required): Experience with TMF, both paper and electronic (eTMF) preferred Where You’ll Work This is a fully remote role. It can be performed effectiv ... (truncated, view full listing at source)