Senior Clinical Trial Associate

Insmed Incorporated • NJ Corporate Headquarters, NJ

5d • $113,000 - $143,500 • Hybrid

About The Position

We’re looking for a Senior Clinical Trial Associate on the Clinical Operations Team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Clinical Trial Operations, 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. In this role, you’ll have the opportunity to drive clinical trial excellence by providing comprehensive operational support across the full study lifecycle — from start-up through closure — ensuring adherence to regulatory standards, GCP guidelines, and inspection readiness while safeguarding the integrity of the Trial Master File and cross-functional collaboration.

Requirements

• Minimum Bachelor’s degree in the life sciences, healthcare, and/or related field.
• Minimum of 3 years of progressive experience in a Clinical Operations role. (Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic Research Organization (ARO), Contract Research Organization (CRO), etc.)
• Demonstrated knowledge of budgetary and financial practices including review and tracking of budget and forecast, opening and tracking activities of purchase orders, payment tracking and process for external parties.
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and local regulatory requirements, etc.
• Proven experience with TMF, both paper and electronic (eTMF) preferred, including Veeva.
• Solid understanding of the DIA TMF Reference Model.
• Strong familiarity with study start‐up activities, including feasibility, country and site activation, patient recruitment efforts.
• Experience with collaborating with CROs and third‐party vendors to ensure successful and quality execution of studies, and builds strong working relationships to create strong team alliances.
• Ability to interact with all global cross‐functional team members to coordinate/execute study activities.
• Demonstrated good communication (verbal and written), conflict management, skills, and highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Demonstrated ability to train and mentor/ new hires and colleagues, as needed.

Nice To Haves

• Experience in rare disease and/or orphan indications is preferred.
• Proactively initiates before asked to assist by colleagues, team members and/or supervisor.

Responsibilities

• Participate in the creation and distribution of study materials, including essential documents, presentations, and reports.
• Assist with the tracking and documenting of site and sponsor training (e.g., study specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team.
• Actively participate in clinical study team and vendor meetings. Schedule meetings, draft and finalize meeting agendas and action items. During clinical study team meetings, provides updates on health and currency of study TMF, and document tracking and currency, tracks and maintains cohesive list of protocol deviations.
• Review CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials.
• Provides cross functional support for inspection readiness preparations. Helps coordinate the retrieval of documents and coordination of other activities, as necessary.
• Participate and help maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure level of detail and adherence to study’s RACT tool.
• 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 help clinical study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
• Responsible for the collection of essential documents and maintenance of electronic Trial Master File. Follows up with CROs, and/or functional area representatives on pending/outstanding documentation in accordance with TMF metrics.
• Assist in preparing TMF Health Reports and collecting TMF status updates and TMF metrics.
• Participate in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor agreements. Assists in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• 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
• Meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Senior