This position for a Senior CRA is open at our office in Berlin, Germany.
LINK Medical is a full-service Nordic CRO providing product development services for the pharmaceutical and medical device industries across Northern Europe. Founded in Oslo, Norway in 1995,we have shown steady growth and now employ over 200 employees from a variety of specialist backgrounds. Our Scandinavian roots and culture enable a high-quality delivery of services based on respect, work integrity, job satisfaction and strong focus on solutions. Our mission is to be a strategic partner, guiding our clients through competence and evidence-based documentation to make optimal decisions that drive superior clinical outcomes. Our promise is to improve and accelerate the product development for our customers through transformative methods, active communication and optimal solutions.
As LINK Medical is growing the portfolio of cross-functional projects is increasing. As a Senior CRA, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas.
Responsibilities
- Complete clinical monitoring and site management tasks according to ICH-GCP, and applicable regulations, timelines, agreements and budget
- Manage and perform monitoring and site management activities related to clinical trials of all phases (I-IV) and in all stages:
- Planning
- Initiation/Set-up
- Conduct
- Close-out
- Plan and organize investigator meetings
- Complete or contribute to EC and CA applications
- Training of study staff and other LINK Medical employees
- Mentoring of junior staff
- Conduct Feasibility
- Develop training material and conduct internal and external courses
Desired qualifications
- Natural science degree at college/university level or comparable
- Generally good IT skills and use of standard office tools
- Fluent in German and English
- Up to date on ICH-GCP including national regulatory requirements
- 1-2 years of experience in monitoring studies and investigator site management
- Experience in Oncology as well as in other therapeutic areas
- Experience in Project Management is an advantage
Personal characteristics
- Service and cooperation minded with excellent communication skills
- Excellent presentation skills
- Resilient towards stress
- Well organized and structured, able to work both independently and in teams
- Independent, flexible, accurate and solution oriented
LINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive salary, trusted working hours, company pension scheme and a subsidy to public transport.
Contact information:
If you would like to know more or have any questions about the position, please contact Uwe Anzenberger (uwe.anzenberger@linkmedical.eu)
All applications are treated confidentially. Local applicants and applicants with permanent residence in Germany will be prioritized.
Last day for application: 2022.07.31
