Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. Along with its unique business model, the success of Debiopharm is also based on its high level of expertise and talented people in various areas such as pre-clinical and clinical trials, manufacturing, drug delivery, formulation, and regulatory affairs. In order to enhance and develop our Clinical Operations Department in Lausanne, we are looking for our new:
Clinical Data Manager
With a solid experience in Data Management
Reporting to the Director, Biostatistics and Data Management, you are accountable for all Data Management activities of clinical trials, in order to ensure completeness, accuracy and consistency of the data delivered on-time. You are a key member of the clinical project team. You are responsible for the set-up, maintenance, control, cleaning and validation of clinical study databases, in compliance with SOPs and regulatory agencies guidelines, in close cooperation with clinical trial managers.
Your main responsibilities and tasks :
- Prepare clinical trials databases: approve CRF design; set-up e-CRFs; test entry screens and databases; parameterise randomisation.
- Prepare data management plans and users guidelines, and train e-CRFs users.
- Maintain clinical trial data accuracy: program edit checks, issue queries, manage resolutions and proceed to automatic coding.
- Lock, transfer and archive databases.
- Ensure adherence to regulations, GCPs, SOPs and working instructions.
- Supervise data management tasks when outsourced.
Your profile :
- Scientific or technical education background, ideally university level.
- Minimum 5 years of experience in clinical trials data management, with proficiency in database programming.
- Experience in all clinical data management activities, from study initiation to database lock.
- Very good working knowledge of at least one clinical trial Electronic Data Capture database application.
- Experience in Clinsight and/or SAS programming will be an advantage.
- Good command of spoken and written English and French.
- Autonomous, able to work independently.
- Team player.
- Able to manage stress and pressure.
Debiopharm can offer you :
An international and highly dynamic environment; the opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry; the possibility to be in a company in which Innovation, People and Entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application using this form.
For more information : www.debiopharm.com
