Senior Lead Clinical Data Manager
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.
As a Senior Lead Clinical Data Manager your key 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 Sponsor, Project Coordinator/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 including the lead of Phase 3 trials from the start until the closure of the database
- 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
A unique opportunity to work in an innovative, dynamic and future-oriented company with a strong international environment. Join IDDI and contribute to the progress of clinical research! An inspiring and exciting career with international and challenging projects is waiting for you! We are looking for motivated, passionate and enthusiastic team players to help our clients accelerate delivery of their drugs. You will work with a dynamic, knowledgeable and international team with extensive clinical trial experience.