AdresseAbiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 2,000 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.
Job Responsibilities:
Reporting to the Manager, Clinical Programs EMEA, the person in this role is responsible for the management of day-to- day aspects of investigational site activities on assigned clinical trials. The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.
Key Responsibilities:
Study start-up and study conduct activities including, approving study specific essential documents list, managing and communicating the status of study progress and activities- Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.
- Participate in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
- Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
- Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
- Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
- Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), GDPR, ISO 14155 and regulatory requirements.
- Manage monitoring progress of contract & CRO CRAs for respective sites.
- Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
- Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.
- Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
- Edit/amend informed consent documents.
Job Qualifications:
Bachelor's Degree or equivalent in related field with 2+ years of previous field monitoring experience (medical device and/or clinical experience) required- Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
- Demonstrated problem-solving and critical thinking skills
- Full working proficiency in English and German,
- Language skills in Italian and/or French is a plus
- Proven expertise in MS Office Suite, including Word, Excel, Adobe
- Experience working in a medical device or regulated industry preferred
- Experience with electronic data capture preferred
- Ability to travel up to 70% required
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
- 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 Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.
