Insmed Incorporated

Clinical Trial Manager - EU

ID
2019-1251
Job Function
Clinical Operations

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!

 

THIS POSITION IS LOCATED IN EUROPE (Preferred home based location Germany, Netherlands, Poland)

 

The Clinical Trial Manager is responsible for the overall management and oversight of clinical trials conducted in Europe 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, close collaboration with investigators and site staff, and management of project timelines and deliverables.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

  • Serves as the leader and coordinator for the management and execution of all clinical trial activities in Europe in compliance with GCP and all other 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
  • Establishes and maintains relationship with EU Investigators and site staff
  • Participates in the development and review of department SOPs and process improvement initiatives

Qualifications

About you!

  • Requires a bachelor’s degree (Masters preferred) in the life sciences, healthcare or related field
  • A minimum of 10 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 and or orphan indications also preferred
  • Demonstrated experience managing CROs and other specialty vendors is essential – Experience at Biotech and CRO preferred
  • Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP R2 requirements and local regulations
  • Demonstrated strong leadership skills and the ability to work successfully in a matrix team environment in a global setting
  • Excellent written and oral communication skills, as well as conflict management, time management and organizational skills
  • Demonstrated computer skills (MS Office, MS Project, PowerPoint)
  • Fluency in English, with knowledge of other European languages a plus

THIS POSITION IS LOCATED IN EUROPE (Preferred home based location Germany, Netherlands, Poland)

 

Travel Requirements:

Able and willing to perform travel, estimated at 30 % with overnight stays (including trips to headquarters in Bridgewater, NJ, USA and trips to investigational sites in Europe)

Additional Information

  • Insmed is an Equal Opportunity Employer and will judge 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. Insmed is an Equal Opportunity Employer.

 

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