Clinical Database Developer (based in Basel or Geneva)
Posted on Sep 9, 2019 by Helvetica Partners Sarl
We are looking for a Clinical Database Developer who will provide Clinical Data Management support to the Clinical Research Department in all phases of projects related to clinical development programs.
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.
At least two years of clinical database development experience is required, gained in the pharmaceutical industry, CRO or Life science related industry.
Some experience working with Oracle and clinical database applications is required.
Knowledge of SQL, PL/SQL, SAS, VBA, Excel, Access and CDISC
Understanding of the research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11
Ability to prioritize multiple tasks and manage time efficiently
Detail-oriented with excellent organizational and communication skills
Fluency in English is required (oral and written).