• Bioanalytical Project Coordinator


• Research Technician/Assistant


• Research Technician/Assistant in Molecular Biology


• Clinical Operations Manager (based in Basel)


• QA Validation Specialist


• Clinical Document Specialist (based in Basel)


• Purification Development Technician/Assistant


• Clinical Database Developer


• Head of Purification & Drug Product Development

Clinical Database Developer

CAREER OPPORTUNITY

Clinical Database Developer (initial 12 month contract)

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

Novimmune is seeking a Clinical Database Developer to join its team and provide Clinical Data Management support to the Clinical Research Department in all phases of projects related to clinical development programs.  

Major responsibilities:

• Databases setup, testing and maintenance


• Data system compliance by following guidelines of international regulatory authorities and internal policies


• Specifications related to data management: data transfers, Data Management Plan (DMP) Data Validation Plan (DVP), internal tools


• Implementation of Edit Checks


• Execution of User Acceptance Tests (UAT) for electronic case report forms (eCRF) and edit checks


• Review of external data specifications


• Data transfers with other functions and CRO


• Design and development of data management tools


• Development and maintenance of procedures and working instructions necessary to support clinical data management conforming to the function quality standards and regulation in the clinical environment.

Candidate should have:

• Minimum 3 years of database development experience working in a pharmaceutical or biotech environment.


• Expert knowledge with Oracle and clinical database applications


• Good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11


• Knowledge of SQL, PL-SQL, SAS, VBA, Excel, Access and CDISC


• Ability to prioritize multiple tasks and manage time efficiently


• Detail-oriented with excellent organizational and communication skills 


• Fluent in English


• Swiss resident or EU national

If your profile matches the above description, please send us your CV and motivation letter in English to hr-recruitment@novimmune.com with reference CDataM/2018.