Senior Clinical Data Manager Opportunity
German based CRO looking to appoint a skilled and motivated Data Manager. The people we want to engage like to work in a consulting environment and have a positive, proactive, self-driven personality. We can offer a highly flexible, free and trustful working environment. With exciting customers and projects in cooperation with competent colleagues. Where your knowledge, experience and your contribution are appreciated and highly valued as Data Manager:
The Senior Clinical Data Manager is responsible for data management deliverables on projects;
- Main contact for clients and internal project team members 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
Background of the Senior Clinical Data Manager;
- Education in computer science, medical documentation or other relevant discipline, or a minimum of 5 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)
- The ideal candidate is a dedicated and collaborative team player.
- 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
