Main Responsibilities:
1. Manages and is accountable for Data Management activities for DM outsourced studies and coordinates: The development of the (e)CRF in line with company standards All study Data Management documents covering specifications for external data transfer, data cleanings and review tools for the allocated study(ies) The monitoring, tracking and testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment Organizes, monitors and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders Generates study metrics and status reports
2. Represents Data Management (Biometry) at Clinical Trial Team (CTT) meetings, investigators and monitors meetings.
3. Provides Data Management input to the development of the study protocol
4. Meets study timelines in terms of Biometry deliverables
5. Prepares and archives Data Management study documentation.
6. Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management.
7. Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP.
Qualifications and Experience:
8. Relevant working/residency permit or Swiss/EU-Citizenship required.
9. Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines.
10. minimum of 5 years’ functional/job relevant experience within Data Management in Biotech
11. In-depth knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH-GCP)).
12. Expertise in (the area of) clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form ((e)CRF) design.
13. Ability to lead and coordinate the activities of Data Management staff allocated to him/her.
14. Good organizational and presentation skills.
15. Experience working with Veeva CDMS or Medidata Rave
16. Fluent in written and spoken English.
17. Knowledge of CDISC standards (SDTM) is highly desirable.
18. Programming proficiency with R, R workbench and/or SAS would be a plus