Abiomed
Clinical Project Manager, EU
Job#: 452666
Positions: 1
Posted: 11/20/2017
Job Type: Full Time
Location: Aachen, Germany
Department: Clinical Training Europe
Salary: Commensurate with Experience
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Job Description

Job Responsibilities:

The Clinical Project Manager plans, designs and implements high quality clinical studies to ensure safety and effectiveness of ABIOMED’s products. They will also provide clinical training for proper device implantation and operation for investigators, cath lab and operating room staff and coronary unit staff.

Principle Duties and Responsibilities:

This is an in-house, strategic role that requires advanced skills in clinical trial management in the business settings. The role requires excellent leadership and organizational skills. As a leader, you will be responsible for the planning, implementation and execution of large global studies. The current role requires you to:

  • Conduct clinical study project setup and management of European clinical trials
  • Run the standard clinical trial operations, assess risks and opportunities during the execution of the trials and propose solutions
  • Communicate with management and study sites to provide information, answers, assistance to ensure good conduct of clinical studies
  • Develop and maintain clinical trial project timeline, manage study budgets and prepare routine operations reports to management
  • Oversee progress made by contracting CRO on weekly a basis
  • Be the study champion, represent ABIOMED and act as the prime contact on behalf on the company with CRO, different vendors and all clinical sites and partners
  • In partnership with other key ABIOMED members, launch strategic initiatives with KOL and other investigators to drive patient/site enrollment and maintain high momentum for the trial
  • Identify trial challenges early in the process, propose potential solutions and lead the team for resolution
  • Prepare and participate in presentation of protocols and other study conduct requirements at study webinars and investigator meetings
  • Ensure clinical trials are compliant with respect to all regulatory and business expectations
  • Mentor and train Jr. Clinical Research Staff




Skills/Requirements

Job Qualifications:

  • Bachelor's or higher degree mandatory
  • 8 years of clinical research trial experience with a Bachelor's degree; or 6 years with a Master’s degree; or a PhD with 3 years of experience
  • Balanced, flexible, humble, open minded, organized, patient, proactive, positive, results-oriented and team player
  • Experience with on-site monitoring of clinical research trials
  • Experience direct management of clinical research investigational sites
  • Demonstrated ability to lead and mentor project team members
  • Experience in Class III cardiovascular device studies preferred
  • Ability to work on multiple protocols at the same time
  • Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA and GCP regulations and practices
  • Proven track record of having good investigator and site relations
  • Excellent interpersonal, verbal, and written communication skills
  • Attention to detail and strong organizational skills
  • Strong knowledge of Microsoft Office Suite and Outlook
  • Must be able to travel up to 50% overnight
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