Lead Clinical Data Manager
In the position of a Lead Clinical Data Manager you are in charge of all aspects of the data management process for important projects. More specifically, your responsibilities would be to:
- Communicate with the sponsor and other collaborators of the project regarding data management issues.
- Produce and maintain study related key Data Management documentation.
- Ensure the eCRF meets the data collection requirements of the study through review of the protocol and other supporting documentation.
- Define and review edit-checks included in the Data Validation Plan as agreed with the sponsor.
- Insure external data (Labs, SAEs, etc…) are transferred and reconciled with the clinical database.
- Perform database lock activities in close collaboration with sponsor, Project Coordinator/Manager, statistician and other parties.
- Develop the Data Management standards ( templates and processes).
For some projects, you would also take the Project Coordinator role to ensure coordination of the activities among the different IDDI departments.
- A University degree, preferably in science
- An Excellent knowledge of the Data Management processes
- A minimum of 5 years of successful Clinical Data Management experience
- A solid experience in EDC systems set-up
- SAS programming knowledge
- CDISC standards knowledge is beneficial for the position
- Fluent in English
- Good planning and analytical skills
- Excellent communication skills
- Resistant to stress