New · posted Oct 31
Insmed · Biotechnology
Senior Clinical Trial Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
We are seeking a Senior Clinical Trial Manager who will be responsible for the management and oversight of global phase I-IV clinical trials from start up through Clinical Study Report (CSR). You will be responsible for the development of project documentation, mentoring and coaching newly onboarded staff, Clinical Trial Associates (CTAs), and Clinical Trial Managers (CTMs), and monitoring study progress. You will manage the administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. You will provide key global trial management support to the Clinical Operations team (e.g., feasibility, start-up, maintenance, and close-out).
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?
Where You’ll Work
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 will be expected.
What you need
Nice to have (but not a must)nice to have
- Experience in rare disease and/or orphan indications.
You have a minimum of Bachelor's degree in the life sciences, healthcare, or related field as well as a minimum of 7 years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.
You are or also have:
- Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills.
- Experience managing global, large and/or early phase complex studies and project teams.
- Demonstrated experience managing global CROs and other specialty vendors.
- Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
- Demonstrated strong leadership skills and the ability to work successfully in matrixed team environment.
- Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or manager.
Travel Requirements
This role requires occasional domestic and international travel (approximately up to 15%).
What you'll do
In this role, you’ll have the opportunity to lead and coordinate the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines as well as may act as Clinical Operations Leader (COL), accountable for trial performance. You’ll also:
- Provide detailed management and oversight of regional/global trial activities, as assigned. Accountable for achieving site activations and enrollment milestones in assigned region. Coordinate cross-functional study clinical team activities to ensure deliverables are completed with high quality, within agreed timelines, and on budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.
- Develop and manage detailed project and other trial-related plans and documentation and provides regular study status updates to senior management. Review and contribute to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials.
- Create, review and approve specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans. Liaises with CRO and legal to provide language acceptable for IRB’s/EC’s.
- Drive timely and efficient execution of site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets.
- Collaborate with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences.
- Accountable for development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites.
- Participate in risk-based quality management (RBQM) activities to ensure data integrity and patient safety. Implement risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials.
- Support COL with planning, and may attend and present at investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
- Responsible for end-to-end vendor management from study planning to close-out, through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
- Collaborate closely with Data Management and other functional areas, vendors, and the CRO to achieve database lock milestones during the project lifecycle.
- Support inspection readiness preparation and maintenance throughout the life-cycle of the trial, including but not limited to ensuring Trial Master File documents are appropriately filed, and reconciled at end of the study.
- Provide guidance/mentoring to assigned program staff (CTMs and CTAs) by demonstrating leadership competencies.
Pay and benefits
$133,000 – $173,000 a year
Employer provided$133,000.00-173,000.00 Annual
Medical, dental and vision coverage
Generous paid time off
401(k) with company match
Annual equity awards and ESPP
Company-paid life and disability insurance
Learning Institute and mentorship programs
From the posting
About Insmed
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.
Equal opportunity, accessibility and legal noticesInsmed's statements, word for word
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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
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 [email protected] 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.
Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $133,000 | — | $173,000 |
| All US (middle half) | $149,000 | $163,000 | $175,000 |
This role: Insmed's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 70 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Insmed's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct15
- Collaboration and leadership14
- GMP and compliance4
- Documentation and SOPs4
- Investigations and CAPA4
- Data and digital systems2
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Insmed on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 3
- Locations
By discipline
- Quality9 39%
- Regulatory7 30%
- Clinical7 30%
By level
- Director13 57%
- Associate & Specialist5 22%
- Manager3 13%
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Senior Clinical Trial Manager at Insmed
Open until filled. $133K–$173K a year, employer provided.