Clinical Data Manager - Early Phase
- Experience Level
The Early Development Services (EDS) division of PRA is a global leader in providing early-phase clinical research and bio-analytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bio-analytical trials on many of the most advanced experimental drugs and biological in development today. Employees of EDS are enthusiastic and dedicated and work in a dynamic informal organization.
Patient Pharmacology Services is a group within EDS focusing on early-phase clinical trials in patient populations. With management offices in Germany, and clinical operations in several cities across Central Europe, we now have an opening for a Data Manager.
Due to growth we are seeking a ClinicalData Manager to be based in our Berlin office.
Working within our Patient Pharmacology Services group your responsibilities will include:
- Clinical database programming in Oracle Clinical and data management for multiple site patient studies.
- Data entry, providing guidelines, querying and clarifying data, and being responsible for consistent study data documentation.
- Leading discussions with Sponsor reviewers, and being responsible for appropriate implementation of their requests.
- Converting database extracted data into standard SDTM (Study Data Tabulation Model) format.
The successful candidate will have both a commercial and clinical focus, with a real commitment to client satisfaction.
A life science or mathematics degree (minimum Bachelor level) is preferred; relevant industry/CRO and/or Oracle Clinical experience would be beneficial but is not required.
You should also have a very good command of German and English. As needed for early phase patient studies, you should be creative and eager to solve also non-standard requirements.
We offer a competitive salary and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scal
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.