Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.
Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.
Job Description:
The Clinical Trial Coordinator (CTC) supports Clinical Project and Program Managers as well as the Academic Research (AR) and Investigator Sponsored Study (ISS) programs in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.
Primary Duties and Responsibilities:
- Plan, coordinate, and arrange study communications and meetings on and off-site with both internal and external attendees
- Prepare all necessary documents for the evaluation of new proposals and coordinate the decision process of new AR or ISS projects
- Manage the grant application platform which maintains all necessary documents and the communication with PI’s
- Set up, update, maintain and close Trial Master Files. Assure currency and accuracy of required clinical trials documents
- Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are received
- Communicate with investigator sites on collection of regulatory documents
- Create study materials, including newsletters, study updates, etc. under the direction of a Scientist or Clinical Program Manager
- Source and distribute study supplies
- Interact with Finance departments to support invoice processing
- Interact with the Sales and Customer service department to support and coordinate external needs and internal processes.
- Under guidance of Clinical Operations management, interact with internal stakeholders and external clients to coordinate the accomplishment of business needs
Job Qualifications:
- BS degree or BS degree candidate with at least two years relevant clinical or basic research experience working at an Investigator Site, Sponsor or Clinical Research Organization
- Familiarity of clinical trial operations, ICH, GCP Guidelines
- Good working experience in a team environment across multi-functional areas
- Highly organized, self-motivated, detail-oriented, proactive, and accurate
- Ability to work with urgency and thrive in a high-energy, fast-paced environment
- Demonstrate excellent communication, verbal and written, and interpersonal skills
- Fluent in written and spoken English
- Demonstrate proficiency in MS Office Suite: Word, PowerPoint, Excel, Project
We offer:
Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives"- Comprehensive induction program with structured onboarding plan throughout the orientation phase
- Company pension allowance of up to 1,500 euros per year and capital-forming benefits
- Abiomed shares at a preferential price
- Benefit packages for occupational disability insurance and company group accident insurance
- Full cost coverage for a job ticket in the Aachen or Berlin area
- Various health programs and a leasing option for a job bike
ABIOMED is an equal opportunity employer. We support equal opportunities for our employees regardless of ethnic origin, skin color, religion, gender, sexual orientation, gender identity, disability or nationality.