A new opportunity has arisen for an experienced Clinical Study Data Manager to join a top pharmaceutical company based in Germany.
Our client is a hugely successful company with a yearly turnover in excess of 31 billion Euros. They are currently looking for an experienced Clinical Study Data Manager, with good knowledge of standardisation (preferably CDISC) to join their well established department.
As a leading bluechip pharmaceutical company they will offer a highly competitive salary, as well as assistance with relocation. If you are looking for a challenging career and a change in lifestyle this could be an ideal opportunity.
As a Senior Study Data Manager, you assume the operational responsibility for all assigned studies and coordinate the activities in the SDM team and the Study Team. Furthermore, you are responsible for the incorporation of the TA and project global standards in the studies. You apply for and administer standard extensions, such as ( e) CRFs , database structures, data derivations , code lists and plausibility issues. Specify and / or develop study-specific data components (Study Metadata) and work closely with the EDC and Data Management Developer Programmer in the specification and design of database structures and eCRF together. They work with the User Acceptance Test. Moreover, the plausibility of questions in the study team to communicate and coordinate and review / acceptance of the implementation of the ‘edit checks ‘in the EDC system or SAS
Your other responsibilities as a Clinical Study Manager will include identifying, addressing and tracking data inconsistencies (queries) , the incorporation of responses and the application of the ‘ Permissible Clarifications ‘ SOP in the EDC system or SAS . In addition, they coordinate the data transfer from and to external data sources (e.g. kinetics, ECG) , prepare the Database Closure Plan , the Study Team and communicate these through the relevant activities . They work in accordance with GCP, relevant Industry Standards and Regulations and standard internal procedures (SOPs).
As a Clinical Study Data Manager you have a university degree (Bachelor, or the like) in natural sciences, computer science or medical documentation. You also have several years experience as Study Data Manager in the project and study teams and have a good understanding of the development process for new drugs. You also bring experience in the supervision of data management teams and coordinating resources. You have a very good communicator and good self-management and organizational skills. They have practical experience in the use of data management methodologies and techniques (eg EDC, SAS) and have experience in dealing with regulations and guidelines.
For more information, or to apply for this Clinical Study Data Manager position, please contact Sarah Brunnen on 01438 743 047 or email email@example.com.