Home to Visionaries
At Greiner Bio-One, we welcome individuals who bring power and ideas, team players who share knowledge and embrace new perspectives, and people who strive for excellence. We are a home for experts, makers, and hidden talents who want to make a significant impact in the health industry.
We Have Future in Our Veins
Your Challenge
1. Set up data management processes for clinical trials of medical devices and in vitro diagnostic products, including creation or selection of an appropriate electronic data capture (EDC) system and non-EDC based data transfer tools.
2. Create or review trial-specific case report forms (CRFs) according to the clinical trial plan and input from the clinical team in a timely manner.
3. Work closely with the clinical project manager and statistician for efficient data cleaning and statistical evaluation throughout the trial, including spot checks, interim analysis, and trial closure.
4. Configure, migrate, and test EDC databases based on internal procedures, trial requirements, and system best practices.
5. Attend trial-specific team meetings and produce status reports and requested metrics, including query information or data trends.
6. Perform data review and generate/close queries.
7. Participate in defining interfaces between data management and existing processes and train colleagues in clinical data management as needed.
Your Profile
1. Mastery of a life sciences-related field or equivalent formal academic qualification.
2. Experience as a technical writer or equivalent for a medical device or pharmaceutical company, demonstrating high attention to detail.
3. Experience with regulatory landscapes for IVDs and MDs is strongly preferred.
4. Experience with MD and/or IVD trials is preferred but not required.
5. Experience in validation is preferred but not required.
6. Effective verbal and written communication in English with internal and external stakeholders, globally.
7. Ability to work independently and reliably in managing multiple project tasks and priorities in a fast-paced international environment.
Our Offer
We offer you an exciting and independent area of responsibility in a modern working environment. Depending on your qualifications and professional experience, you may be eligible for overpayment.