Senior Clinical Data Manager

Senior Clinical Data Manager

Copenhagen

Description
Are you motivated and action-oriented for achieving results and reaching timelines? Do you hold a high standard within the field of study set-up and study conduct? If yes, then you might be our new colleague within Clinical Data Management

Clinical Data Management is part of the department Data management and Programming in Biometric Division. We work closely together with our Biometrics colleagues and other study functions inside the company. We are currently looking for a Senior Clinical Data Manager to take on study CDM responsibilities for all phases as well as SDTM mapping, light programming and project management.

We offer a challenging job in Copenhagen in a dynamic and open working atmosphere with a focus on personal and scientific development.

Your job and key responsibilities
As the study CDM, you are the Clinical Data Management representative on the Study Management Team (SMT). You will be responsible for managing the end-to-end data management process from study start to database release. Process steps include giving input to study documents, setting up the eCRF, including programming of checks, coordinate and drive the data cleaning process, reconcile eCRF data with external data and making sure data management documents are properly archived. The members of the SMT are your primary stakeholders.

You would also be involved in SDTM mapping and the creation of smaller checks on the SDTM data (SAS programming).

Qualifications

* You have a Bachelor's degree in a science-related field.
* You have at least 4 years' data management and/or related work experience in an international medical device or pharmaceutical company.
* You have working knowledge of Clinical database EDC applications preferably RAVE®.
* You are familiar with CDISC and have hands-on experience with SDTM mapping.
* You have SAS programming.
* You are fluent in English.