Clinical Trial Manager

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

Responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a, 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, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key trial management support to the Associate Directors (CST Leads), as assigned.

Responsibilities

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 and 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.• Manages global monitoring oversight of site-level activities related to ongoing and planned trials• 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.Bachelor's degree in the life sciences, healthcare, or related field.• Minimum of 5+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.• Experience in rare disease and/or orphan indications is preferred.• Experience managing large and/or complex studies and project teams is preferred. Experience in rare disease and/or orphan indications is preferred.• Demonstrated experience managing CROs and other specialty vendors is essential.• 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 limited oversight and proactively initiat