Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
As one of the largest biotechnology companies in Germany, we research, develop and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B•R•A•H•M•S is based in Hennigsdorf near Berlin, which is home to about 145 of the company’s 550 employees worldwide.
We´re looking at our site in Hennigsdorf for a
Discover Impactful Work:
We are looking for you to strengthen the Global Medical Affairs team of the Biomarker Business Unit as soon as possible. In this position you will supervise the conduct of clinical trials at Global Medical Affairs and work closely with national and international study centers.
A day in the Life:
You are part of a team that proves, documents and scientifically communicates / publishes the clinical performance and benefits of Thermo Fisher Scientific biomarkers in the context of clinical trials.
You will be responsible for coordinating the GCP-compliant implementation of clinical study projects, including monitoring, and will work closely with various internal departments such as Marketing, Regulatory Affairs and Development as well as external partners (primarily in English).
You will evaluate study protocols and project plans and take over the monitoring and coordination of study-related activities, also with regard to time and budget targets.
You report regularly on the progress of the project/study and communicate important study results internally and externally.
Within the scope of your study projects, you take over the contract management and maintain contact with opinion leaders and external medical experts.
You will prepare and update documents for the performance evaluation of IVDs (e.g. literature search and evaluation, assessment of analytical and clinical performance).
Keys to Success:
Education:
Experience:
Profound professional experience in clinical trial management, especially as CRA, preferably in the field of IVD/biomarkers
Practical knowledge in project management
Sound knowledge of IVD-R, MPG and ICH-GCP
Experience in dealing with regulatory authorities
Medical writing skills
Willingness to solve a wide range of tasks requiring flexible or systematic work with accurate documentation
Knowledge, Skills, Abilities:
Very good communication skills
High personal motivation and the ability to work systematically under changing demands
Basic understanding of diagnostic biochemical or immunological procedures as well as of IVD or biomarkers is an advantage
Knowledge of clinical procedures desirable
Very good written and spoken English
Willingness to travel
What we offer:
Employment with an innovative, future-oriented organization
Outstanding career and development prospects
Company pension scheme and other fringe benefits
Exciting company culture which stands for integrity, intensity, involvement and innovation
If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
Agency notice!
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.
