Clinical Trial Manager, Clinical Operations - EU | BioNJ Talent Services

Clinical Trial Manager, Clinical Operations - EU

Contact Information
Contact Name: 
Insmed
Organization Name: 
Insmed
Position Location: 
Insmed, Germany
Company Profile: 

Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.

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.

Job Description:

SUMMARY:

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.

This position is a home-based role that may be located anywhere in Germany.

RESPONSIBILITIES:

•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: 

•Requires a Bachelors 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 indications 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 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
•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 Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Operations