[Hiring] Senior Clinical Trial Manager @Insmed Incorporated

Role Description

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

• Lead and coordinate the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
• Act as Clinical Operations Leader (COL), accountable for trial performance.
• 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.
• Develop and manage detailed project and other trial-related plans and documentation.
• 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.
• Liaise with CRO and legal to provide language acceptable for IRB’s/EC’s.
• Drive timely and efficient execution of site feasibility assessments.
• Collaborate with regional MSLs (if applicable) to support investigator engagement activities.
• 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.
• 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.
• 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.
• Provide guidance/mentoring to assigned program staff (CTMs and CTAs) by demonstrating leadership competencies.

Qualifications

• Minimum of Bachelor's degree in the life sciences, healthcare, or related field.
• Minimum of 7 years of clinical trial management experience within pharmaceutical/biotechnology industry.
• Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring.
• 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.

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%).

Pay Range

$133,000.00-173,000.00 Annual

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• 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.