Currently, we are looking for a Clinical Data Manager to join our team in Estonia.
DM provides training and support to Crown CRO employees. DM contributes to the overall success of Crown CRO and its customers by establishing and sharing good knowledge on data services and good customer relations. DM ensures efficient performance of a trial in delivering cost-effective high-quality data on time.
Study specific main tasks
DM completes and/or oversees activities according to the agreed scope of work, quality standards, timelines, and budget. DM responsibilities include, but are not limited to:
- Standard Operating Procedure (SOP) and/or process creation and implementation.
- Performs or oversees all Data Services activities in assigned trials, including, but not limited to:
- EDC study design planning and creation
- Creation, review and/or approval of all applicable DS trial documentation
- Database User Acceptance Testing
- Data review
- Medical coding
- Trains all applicable Crown CRO staff on DS processes.
- In operational work acts as the Project Data Manager, if applicable.
- Supports project team members in planning of complex trials.
- Communicates with Sponsors as required.
- Updates the line manager, as required, on the status of projects and tasks.
- Provides cross-functional support to other Crown CRO units.
DM has a scientific, health care or IT education and 3 years of relevant data management experience in contract research organizations and/or pharmaceutical industry, with team leading experience in Data Management.
The following skills and attributes are required from DM:
- Understanding SOPs, EU and local regulatory requirements, and ICH GCP and GCDMP guidelines
- Strong organisational, documentation, and interpersonal skills and willingness to work in a team-oriented environment
- Excellent command of written and spoken English
- Good computer skills
- Know-how of EDC systems
- Microsoft Office tools
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
For additional information, please contact Raivo Verk, email – email@example.com.
We are keen to hear from you! Please send your application, CV and salary request to firstname.lastname@example.org no later than October 9th 2020.
Location: Estonia (home-based)
Job type: full-time, employee