In the position of Senior Lead Clinical Data Manager, you will be in charge of all aspects of the Clinical Data Management process for important projects.
Your responsibilities will be to:
- Ensure that all CDM deliverables for the study including the SAS database are delivered on time with the expected quality.
- 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 CRF 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 unblinding and lock activities in close collaboration with the sponsor, Project Manager, statistician and other parties.
- Develop the Data Management standards (templates and processes).
- A University degree, preferably in science
- A minimum of 5 years of successful Clinical Data Management experience
- 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
We offer a permanent position in an innovative and dynamic company.