Associate, Clinical Trial Business Operations

Company: Insmed Incorporated
Location: Bridgewater
Posted on: February 7, 2026

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’re looking for an Associate, Clinical Trial Business Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Clinical Systems & TMF Operations, you’ll be responsible for performing TMF management activities such as document filing, quality control reviews, and audit/inspection support. This role supports the cross-functional clinical trial team with document management expertise and assists in ensuring TMF completeness and compliance overseeing both the internal and any externally held Trial Master Files. This role is remote and can be located anywhere in the United States. What You'll Do: In this role, you’ll have the opportunity to assist with set-up or new studies in Insmed and/or CRO eTMF system and provide review of related documents (e.g., TMF Plan, Index, Expected Document List (EDL), etc.). You’ll also: Work with CRO and Insmed cross-functional team members on the review and submission of TMF records to eTMF. Assist CTAs in maintaining study TMF mailboxes to ensure timely document filing. Perform and/or oversee Filing QC of documents (paper and electronic) submitted to the TMF. Support the coordination of the transfer of study-specific TMF from the CRO and assists with activities for archival of paper/electronic TMFs. Support development and standardization of TMF reporting and analytics. Provide input into SOP and WI development for TMF-related processes. Participate in Clinical Study Team meetings and provides/presents regular TMF metrics updates. Maintain awareness of study events, milestones, and associated documentation requirements through collaboration with Clinical Study Team Who You Are: You have a Bachelors degree along with 3 years of experience in Electronic Trial Master File management. You are or you also have: Veeva Vault experience 3 years of Clinical Operations or related training. Advanced working knowledge of CDISC TMF filing structure Thorough understanding of clinical trial operations, ICH/GCP guidelines and FDA regulations General knowledge of medical terminology Proven ability to work with a high level of integrity, accuracy, and attention to detail. Strong technical/analytical skills to identify and solve problems LI-TB1 LI-Remote Pay Range: $87,000.00-111,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Keywords: Insmed Incorporated, Toms River , Associate, Clinical Trial Business Operations, Healthcare , Bridgewater, New Jersey