Clinical Trial Coordinator - Aachen, Deutschland - Abiomed

Abiomed

Geprüftes Unternehmen

Aachen, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts.

Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore.

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.

The Sr.

Clinical Trial Coordinator (CTC) supports Clinical Project and Program Managers 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 offsite with both internal and external attendees
Set up, update, maintain and close Trial Master Files. Assures currency and accuracy of required clinical trials documents
Maintain projectspecific 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 templates, etc. under the direction of the Clinical Project Manager and Clinical Program Manager
Source and distribute study supplies
Interact with Finance departments to supports invoice processing process
Under guidance of Clinical Operations management, interact with internal and external clients to coordinate the accomplishment of business needs

Job Qualifications:

Familiarity of clinical trial operations, ICH, GCP Guidelines
Good working experience in a team environment across multifunctional areas
Highly organized, selfmotivated, detailoriented, proactive, and accurate
Ability to work with urgency and thrive in a highenergy, fastpaced environment
Demonstrate excellent communication, verbal and written, and interpersonal skills
Experience working with eTMFs and CTMS systems
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 capitalforming benefits
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.