Insmed Incorporated · 5 hours ago
Associate, Clinical Trial Business Operations
United States
Full-time
Remote
Mid Level
$87K/yr - $111K/yr
3+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Associate, Clinical Trial Business Operations will perform TMF management activities, support the clinical trial team with document management expertise, and ensure TMF completeness and compliance.
BiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelors degree
3+ years of experience in Electronic Trial Master File management
Preferred
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
Benefits
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Roger Adsett
Chief Operating Officer
Recent News
2026-01-13
Company data provided by crunchbase