We’re looking for a Senior Associate, Clinical Trial Operations on the Clinical Operations - Gene Therapy Team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Clinical Operations - Gene Therapy, 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 ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.What You'll Do:Support Clinical Operations through study start-up, patient recruitment, maintenance, and study closure activities.Coordinate the creation and distribution of study materials, including essential documents, presentations, and reports.Lead site and sponsor training tracking, assign study-specific plans via Insmed's Learning Management System (LMS).Track essential study milestones and maintain study trackers (e.g., team roster) to support study oversight.Facilitate logistics for Investigator Meetings held by third-party vendors in collaboration with Insmed.Serve as the point of contact and liaison for the Medical Review Committee (MRC).Drive clinical study team and vendor meetings by scheduling, drafting agendas, capturing action items, and documenting decisions.Review and submit CRO/vendor contractual documents, work orders, change orders, and amendments into Procurement and legal approval systems.Assess CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials.Partner with Quality Assurance to support audits, inspections, and regulatory body inspection readiness, including document retrieval and CTA inspection readiness checks from startup through closeout.Process clinical trial invoices and liaise with Finance to create purchase orders and requisitions via the Procurement system.Mentor and train CTAs as appropriate.Maintain the Trial Master File (TMF), lead periodic TMF QC checks, and oversee Sponsor- and CRO-supported TMF quality activities per ICH/GCP requirements.Report TMF metrics, identify risks and trends, and follow up with CROs and functional area representatives on outstanding issues.Conduct monitoring, co-monitoring, and oversight monitoring activities to support ongoing clinical trial oversight.Who You Are:You have a minimum Bachelor's degree in sciences or a related field along with 3+ years of progressive experience in a Clinical Operations role on the sponsor side or 5+ years at a CRO.Demonstrated hands-on monitoring experience along with a solid understanding of clinical research processes, including all functional areas of clinical trials, medical terminology, and FDA/local regulatory requirements.Ability to apply proven knowledge of budgetary and financial practices, including budget review and forecasting, purchase order management, and payment tracking for external parties.Extensive experience with Trial Master Files (TMF), both paper and electronic (eTMF), including Veeva, with a strong understanding of the DIA TMF Reference Model.Experience executing study start-up activities with confidence, including feasibility assessments, country and site activation, and patient recruitment efforts.Able to collaborate effectively with CROs and third-party vendors to ensure quality study execution and build strong, productive team alliances.Ability to coordinate seamlessly with global cross-functional team members to plan and execute study activities across all regions.Ability to communicate clearly and effectively — both verbally and in writing — while demonstrating strong conflict management skills and a high level of organization, attention to detail, and accuracy.Nice to have (but not required):Experience in rare disease and/or orphan indications is preferred.Demonstrated ability to train and mentor new hires and colleagues, as needed.This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.This role requires occasional [domestic/international/global] travel (approximately 25%).Life at InsmedHighlights 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 collaboration401(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 insuranceCompany Learning Institute providing access to Linkedll building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan.
2 months ago