Insmed Incorporated · 14 hours ago
Associate, Clinical Trial Operations
Headquarters, NJ
Full-time
Hybrid
Entry Level
$87K/yr - $111K/yr
2+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Associate, Clinical Trial Operations will assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team, managing multiple clinical trials, and ensuring compliance with regulations and guidelines.
BiotechnologyMedicalPharmaceutical
Responsibilities
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
Be responsible for the collection of trial-related documents and maintenance of both paper and electronic Trial Master File
Assists in periodic Trial Master File quality control check through the course of study as defined by the clinical study team, per ICH/GCP requirements
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
Follow up with CROs and functional area representatives on outstanding documentation in accordance with TMF metrics
Participate in the review of clinical trial agreements, work orders, and other site/vendor agreements. Assists 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 finalizes meeting action items. During CST meetings, provides 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)
Qualification
Required
Bachelors degree
Minimum of 2+ years of experience in pharmaceutical and/or biotechnology industry
Experience in clinical research
Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines in clinical trials
Good verbal communication and writing skills
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
Must successfully exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity
Preferred
Experience with TMF, both paper and electronic (eTMF)
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