Germany Job Openings
Merz Aesthetics GmbH
(Senior) Clinical Data Manager (m/f/d), Biometrics
Frankfurt am Main
October 17, 2024
The following responsibilities are awaiting you:
- You define trial-specific data management procedures in the Data Management Plan.
- You coordinate the development, administration, and updates of the e CRF, including the e CRF User Acceptance Test and the definition of user roles and user administration procedures.
- You define trial-specific edit checks and discrepancy management procedures in the Data Validation Plan.
- You organize and specify transfers for data collected outside of the e CRF (e.g., diary, lab, photo).
- You define the content of regular status reports and manage their distribution.
- You oversee medical coding with Med DRA and WHO-DD.
- You conduct and oversee SAE/AESI reconciliation and resolve resulting discrepancies.
- You coordinate database freeze and close activities.
- You archive the clinical database and subject (e)CRFs.
- You control CRO performance of data management activities, including participation in CRO selection, reviews, QC measures, and data transfers.
- You optimize and update data management processes to reflect possible changes in regulatory requirements.
- You have a Master’s degree or equivalent qualifications in Documentation, Medical Informatics, Bioinformatics, Natural Sciences, or a similar field.
- You have at least 3 years of experience in Clinical Data Management.
- You are proficient in English, both written and spoken.
- You are knowledgeable about ICH, GCP, and FDA Guidelines.
- You have experience with EDC systems as well as first knowledge with SAS.
- You have first CDISC experience.
- You possess excellent organizational skills and an analytical, structural way of thinking.
- You have a high sense of responsibility and quality awareness.
- You are a good team player with strong communication skills.
Family and work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.
Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.
Ongoing training: Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.
Find out more about our benefits at https://careers.merz-aesthetics.com.
We look forward to your application!
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