The Clinical Development Unit is the corporate centre for development and execution of Nestlé clinical trails worldwide. The Clinical Operations group within this Clinical Development Unit is responsible for high quality and timely execution of the global clinical trials, compliant with international standards, ICH-GCP and regulatory requirements. Clinical Operations is primarily located in Lausanne but has various regional offices that are responsible for clinical trial management within their region.
To support its research operations, the Clinical Development Unit based at the Nestlé Research Centre in Lausanne is seeking a:
Clinical Data Manager
Temporary Assignment (2 years contract)
The candidate should be able to manage all the data management steps of our clinical trials to achieve timely delivery of quality results while respecting clinical trial good clinical practices (GCP) and internal method and processes.
- Take operational decisions concerning implementation of database to achieve timely delivery of good quality results.
- Define the best way to achieve optimum data management of clinical trials, including the choice of specific data management method (paper or electronic).
- Review and update protocols, and design Case Report Forms in collaboration with the project team.
- Prepare and maintain key documents for the Data Management of Clinical Trials.
- Set up the database, including consistency checks defined in the Data Validation Plan.
- Follow the Data Entry workflow and download data from external source.
- Liaise with Biostatisticians concerning data validation and lock of the database, including management of discrepancies.
- MSc. degree with scientific background.
- Clinical data manager with 2-3 years of experience.
- Knowledge of data management tools such as ClintrialTM, RaveTM(Medidata).
- Excellent oral and written communication skills in English, other languages are a plus.
- Programming SQL, PL-SQL, SAS, C#.
- Knowledge of clinical trial regulations.
- Knowledge in nutrition is an asset.
- Ability to manage multiple studies simultaneously.
- Well organized and independent,
- Focused on quality and delivery.
- Strong team spirit, trustworthy, flexible and meticulous.
Deadline: May 24, 2013