Clinical Data Manager

vor 4 Wochen


Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

Job Summary: We are seeking a highly skilled Clinical Data Manager to join our team at Merz Aesthetics GmbH. As a Clinical Data Manager, you will be responsible for defining trial-specific data management procedures, coordinating the development and administration of eCRFs, and overseeing medical coding with MedDRA and WHO-DD.

Responsibilities:

  • Define trial-specific data management procedures in the Data Management Plan.
  • Coordinate the development, administration, and updates of the eCRF, including the eCRF User Acceptance Test and the definition of user roles and user administration procedures.
  • Define trial-specific edit checks and discrepancy management procedures in the Data Validation Plan.
  • Organize and specify transfers for data collected outside of the eCRF (e.g., diary, lab, photo).
  • Define the content of regular status reports and manage their distribution.
  • Oversee medical coding with MedDRA and WHO-DD.
  • Conduct and oversee SAE/AESI reconciliation and resolve resulting discrepancies.
  • Coordinate database freeze and close activities.
  • Archive the clinical database and subject (e)CRFs.
  • Control CRO performance of data management activities, including participation in CRO selection, reviews, QC measures, and data transfers.
  • Optimize and update data management processes to reflect possible changes in regulatory requirements.

Requirements:

  • A Master's degree or equivalent qualifications in Documentation, Medical Informatics, Bioinformatics, Natural Sciences, or a similar field.
  • At least 3 years of experience in Clinical Data Management.
  • Proficiency in English, both written and spoken.
  • Knowledgeable about ICH, GCP, and FDA Guidelines.
  • Experience with EDC systems as well as first knowledge with SAS.
  • First CDISC experience.
  • Excellent organizational skills and an analytical, structural way of thinking.
  • A high sense of responsibility and quality awareness.
  • A good team player with strong communication skills.

About Us: Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.


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