Sr. Manager, Clinical Trial Operations

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.

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

About the Role :

Responsible for the management and oversight of global phase I-IV clinical trials, with a key focus on Ph2b-3, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Key global trial management support to the Associate Directors (CST Leads), as assigned. This role can be hybrid or remote.

What You'll Do :

• Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
• Detailed management and oversight of regional trial activities, as assigned.
• Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.
• Effectively manages and / or assists with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings / discussions and ensuring effective risk management planning.
• Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff.
• Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management.
• Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders.
• Provides coaching / mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies.
• Works collaboratively with Clinical Scientist, Clinical Indication / Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.
• Proactively identifies potential resource needs to management.
• Participates in the development and review of department SOPs and process improvement initiatives.

Who You Are :

Pay Range : $119,000.00-167,267.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our missionintentionally 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 :

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