Description

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
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.

What You'll Do:

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.

You'll also:

• 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.

Who You Are:

You have a minimum Bachelor's degree in the life sciences, healthcare, and/or related field along with 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.)

You are or you have:

• 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 have (but not required):

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

Where You'll Work

This is a hybrid role based out of our Bridgewater, New Jersey office. You'll work remotely most of the time, with in-person collaboration when it matters most.

Travel Requirements:

This role requires occasional domestic travel (approximately 5%)

Pay Range:
$113,000.00-143,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights 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 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.