Insmed Incorporated

Clinical Trial Manager

ID
2019-1258

Company Description

About Insmed!

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

 

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

 

Overview

About the role!

The Clinical Trial Manager is responsible for the overall management and oversight of phase I-IV clinical trials 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

 

Responsibilities

 Responsibilities: 

  • Serves as the leader and coordinator for the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines
  • Effectively manages the cross-functional study team 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 project staff
  • Develops and manages detailed project plans 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 change orders
  • Provides coaching/mentoring to assigned project staff (CRAs, and CTAs) by demonstrating leadership competencies
  • Proactively identifies potential resource needs to management
  • Participates in the development and review of department SOPs and process improvement initiatives

Qualifications

About You!

  •   Bachelor's degree in the life sciences, healthcare or related field
  • A minimum of 5 years of clinical trial management experience within the pharmaceutical/biotechnology industry, managing the logistics of clinical trial execution
  • Experience managing large and/or complex studies and project teams is preferred. Experience in respiratory indications or rare disease also 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 a matrix team environment
  • Excellent written and oral communication skills, as well as conflict management, time management and organizational skills
  • Demonstrated strong computer skills (MS Office, MS Project, PowerPoint)

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. This position is also bonus eligible.

 

Insmed is an Equal Opportunity Employer and will evaluate all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local 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.

 

Please note that we review every submission and we will keep all submissions on file for six months.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.