Senior Clinical Trial Manager

Insmed Incorporated•NJ Corporate Headquarters, NJ

5d•$133,000 - $173,000•Remote

About The Position

Insmed is seeking a Senior Clinical Trial Manager to manage and oversee global Phase I–IV clinical trials from start-up through Clinical Study Report (CSR). The role includes developing project documentation, mentoring newly onboarded staff, Clinical Trial Associates (CTAs), and Clinical Trial Managers (CTMs), monitoring study progress, overseeing study budgets, managing third-party clinical service vendors, and coordinating project timelines and deliverables. The position also provides global trial-management support across feasibility, start-up, maintenance, and close-out. The Senior Clinical Trial Manager leads and coordinates clinical trial activities in compliance with GCP and applicable regulatory guidelines and may serve as Clinical Operations Leader (COL), accountable for trial performance. The role works across regional and global teams to meet site activation and enrollment milestones, deliver high-quality work on time and within budget, support effective risk management, and maintain inspection readiness and trial documentation. This is a fully remote role that can be performed from anywhere while staying connected with the Insmed team. Occasional domestic and international travel, approximately up to 15%, is expected. The listed annual pay range is $133,000–$173,000.

Requirements

Bachelor’s degree or higher in life sciences, healthcare, or a related field.
At least 7 years of clinical trial management experience in the pharmaceutical or biotechnology industry, managing clinical trial execution logistics.
At least 2 years of indirect or influence management of team members, including coaching and mentoring to support knowledge-sharing, communication, and leadership skills.
Experience managing global, large, and/or complex early-phase studies and project teams.
Demonstrated experience managing global CROs and other specialty vendors.
Thorough understanding of drug development and clinical trial execution, including ICH/GCP requirements and local regulations.
Strong leadership skills and ability to work successfully in a matrixed team environment.
Ability to work independently with minimal oversight and proactively assist colleagues or a manager.
Ability to travel occasionally domestically and internationally, approximately up to 15%.

Nice To Haves

Experience in rare disease and/or orphan indications.

Responsibilities

Manage and oversee global Phase I–IV clinical trials from start-up through Clinical Study Report (CSR).
Lead and coordinate clinical trial activities in compliance with GCP and relevant regulatory guidelines; may act as Clinical Operations Leader accountable for trial performance.
Manage assigned regional and global trial activities and achieve site activation and enrollment milestones in the assigned region.
Coordinate cross-functional study team activities to complete deliverables with high quality, within timelines and budget, using effective information-sharing, study meetings, and risk-management planning.
Develop and manage project plans and trial-related documentation, and provide regular study status updates to senior management.
Review and contribute to clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials.
Create, review, and approve study documents, including informed consent forms, study guidelines, operations manuals, training materials, and study plans; liaise with CROs and legal teams on language acceptable to IRBs/ECs.
Lead timely site feasibility assessments with Clinical Development, Medical Affairs, and Clinical Operations colleagues, evaluating site capabilities, patient access, investigator experience, and therapeutic-area expertise to inform site selection and enrollment planning.
Collaborate with regional MSLs, where applicable, to support investigator engagement; may help organize investigator engagement meetings or events at industry congresses and conferences.
Develop action plans to address protocol compliance, safety, data, and administrative issues at investigator sites.
Participate in risk-based quality management activities and implement risk-based and centralized monitoring strategies with CROs when applicable; these strategies are not applicable to early-phase trials.
Support the COL with planning and may attend and present at investigator meetings, kick-off meetings, monitoring training, and CRO or other vendor meetings.
Manage vendors end-to-end from study planning through close-out, reviewing study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
Collaborate with Data Management, other functions, vendors, and the CRO to achieve database-lock milestones.
Support inspection-readiness preparation and maintenance throughout the trial, including appropriate Trial Master File filing and reconciliation at study end.
Guide and mentor assigned program staff, including CTMs and CTAs.
Provide global trial-management support to Clinical Operations across feasibility, start-up, maintenance, and close-out.

Benefits

Comprehensive medical coverage
Dental coverage
Vision coverage
Mental health support
Annual wellbeing reimbursement
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 competitive company match
Annual equity awards
Employee Stock Purchase Plan (ESPP)
Company-paid life insurance
Company-paid disability insurance
Company Learning Institute with access to LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups
Service and recognition programs
Opportunities to connect, volunteer, and give back