Senior Clinical Trial Manager

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 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).

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. 

Who You Are:

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. 

Nice to have (but not a must):

• Experience in rare disease and/or orphan indications.

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.  

Travel Requirements 

This role requires occasional domestic and international travel (approximately up to 15%).

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Pay Range:

$133,000.00-173,000.00 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

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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.

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