Clinical Trial Manager

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 patientsfirst 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.

Consistently Ranked Sciences 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. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences 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 Workcertified 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.

• Leads and coordinates the management and 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 thirdparty suppliers to contracted deliverables within quality cost and timeline parameters.
• Effectively manages and/or assists with crossfunctional clinical study team and team members to achieve deliverables with high quality on time and within budget through informationsharing 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 sitelevel activities related to ongoing and planned trials
• Develops and manages detailed project and other trialrelated 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.

• Bachelors 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 .
• 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 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 initiates before asked to assist colleagues and/or manager
• Possess critical thinking skills for problemsolving conflict resolution collaboration and interpretation
• Excellent written and oral communication skills as well as conflict management time management and organizational skills.
• Must successfully exhibit Insmeds five 5 core corporate competencies of: Collaboration Accountability Passion Respect and Integrity; along with any other position specific

At Insmed were committed to investing in every team members total wellbeing now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:

• Flexible approach to how we work
• Health benefits and timeoff plans
• Competitive compensation package including bonus
• Equity Awards (LongTerm Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

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 atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase 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.