Senior Associate, Clinical Trial Operations - Gene Therapy

About the role

We're seeking a Senior Associate, Clinical Trial Operations for our Clinical Operations - Gene Therapy Team. Reporting to the Executive Director, Clinical Operations - Gene Therapy, you'll provide operational support to the clinical study team (CST) and manage multiple clinical trials.

Responsibilities

• Support the delivery of Clinical Operations objectives by assisting the CST with trial management.
• Coordinate the creation and distribution of study materials, including essential documents, presentations, and reports.
• Lead site and sponsor training tracking, maintain training matrices, and 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) on site/patient-facing materials.
• 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 conduct 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.

Qualifications

• A minimum Bachelor's degree in healthcare, life sciences, or a related field.
• 3+ years of progressive experience in a Clinical Operations role on the sponsor side or 5+ years at a CRO.
• 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.
• Ability to collaborate effectively with CROs and third-party vendors to ensure quality study execution and build strong, productive team alliances.
• Able to coordinate seamlessly with global cross-functional team members to plan and execute study activities across all regions.
• Able 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.

Skills

• Hands-on monitoring experience.
• Strong understanding of clinical research processes, including all functional areas of clinical trials, medical terminology, and FDA/local regulatory requirements.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage and mental health support, generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. We also provide a 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. We offer access to our Employee Assistance Program (EAP), and current Insmed Employees can apply via the Jobs Hub in Workday.

Pay

$113,000.00 - $143,500.00 Annual