Data Manager - Munich, Germany

Data Manager – Munich, Germany


KLIFO is looking for an experienced Data Manager for our Munich office

The position as Data Manager:

The Data Manager is responsible for data management deliverables on projects conducted by KLIFO:

  • Act as the primary contact person for clients concerning data management aspects
  • Provide data management consultancy on general or trial related aspects
  • Cooperate closely with study team members such as biostatisticians, medical reviewers and project managers
  • Writing or peer review of Data Management Plans and Data Validation Plans
  • Coordination and instruction of data entry personnel, data entry
  • Database set-up and testing, within an eCRF system or using SAS, including relevant documentation
  • Set-up and testing of online edit checks
  • Programming and tracking of queries
  • Program (within an eCRF system or in SAS®) various listings, overviews and summary tables for medical reviewer, status reports, project management; provide updated outputs on a regular basis
  • Support programming of data listings for clinical study reports
  • Perform quality control of programs and of customisations of software, e.g. UAT of EDC, including relevant documentation
  • Continuous data cleaning, data base lock
  • Medical coding according to MedDRA and WHO-DD
  • Arrange data import/export from/to external sources (e.g. central laboratory)
  • Provide input to Risk Based Quality Management (RBQM) including risk assessment and risk controls
  • Support maintenance and further development of internal standards and of Standard Operating Procedures

Qualifications of the Data Manager

  • Education in computer science, medical documentation or other relevant discipline, or a minimum of 3 years in a similar position in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Ability to translate client’s needs into data management practice
  • Knowledge of relevant regulatory guidelines and data protection requirements
  • Good knowledge of SAS®
  • Good knowledge of Microsoft Office
  • Good verbal and written communication skills
  • Good knowledge of English (spoken and written)
  • Understanding of medical terminology and relevant coding dictionaries (MedDRA, WHO-DD)

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Use – and elaborate – your competences and experience
  • A team of experienced colleagues
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in Glostrup, Denmark,  Munich, Germany and Lund, Sweden. This position is located at our office in Munich.

Contact:

For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0.

Applications should be sent to:

moc.ofilk@boj, marked ‘Data Manager Munich Office’.
Wir freuen uns auch über Bewerbungen auf Deutsch.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

KLIFO is an established and integrated drug development consultancy with offices in Denmark and Germany. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

Further information about KLIFO can be found at www.klifo.com

View job post as a PDF.